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Back to Companies who have applied for FDA Drug Approval
FDA Drug Approval Applications Sponsored by MYLAN
Application Number
Drugs/Products
Application Type
Most Recent Label Available Flag
Current Patent Flag
Action Type
Chemical Type
Ther Potential
Orphan Code
018487
FUROSEMIDE
New Drug Application
Approval
018659
ALLOPURINOL
Abbreviated New Drug Application
Approval
018858
INDOMETHACIN
New Drug Application
Approval
020392
CYSTAGON
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
(V) Orphan drug
020400
AVITA
New Drug Application
Approval
New manufacturer
(S) Standard review drug
020524
MENTAX
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
020677
ZAGAM
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
021408
MENTAX-TC
New Drug Application
Approval
New formulation
(S) Standard review drug
040185
PROCHLORPERAZINE MALEATE
Abbreviated New Drug Application
Approval
040209
TRIFLUOPERAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
040274
HYDROXYCHLOROQUINE SULFATE
Abbreviated New Drug Application
Approval
040298
EXTENDED PHENYTOIN SODIUM
PHENYTEK
Abbreviated New Drug Application
Approval
040317
DICYCLOMINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
040319
DICYCLOMINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
040326
ESTRADIOL
Abbreviated New Drug Application
Approval
040350
METHIMAZOLE
Abbreviated New Drug Application
Approval
040359
ESTROPIPATE
Abbreviated New Drug Application
Approval
040415
WARFARIN SODIUM
Abbreviated New Drug Application
Approval
040424
SPIRONOLACTONE
Abbreviated New Drug Application
Approval
040569
PROPOXYPHENE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
040594
MERCAPTOPURINE
Abbreviated New Drug Application
Approval
060752
PENICILLIN G POTASSIUM
Abbreviated New Drug Application
Approval
060781
PENICILLIN G POTASSIUM
Abbreviated New Drug Application
Approval
060783
TETRACYCLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
061505
ERYTHROMYCIN STEARATE
Abbreviated New Drug Application
Approval
061530
PENICILLIN V POTASSIUM
Abbreviated New Drug Application
Approval
061624
PENICILLIN V POTASSIUM
Abbreviated New Drug Application
Approval
061755
AMPICILLIN TRIHYDRATE
Abbreviated New Drug Application
Approval
061829
AMPICILLIN TRIHYDRATE
Abbreviated New Drug Application
Approval
062067
AMOXICILLIN
Abbreviated New Drug Application
Approval
062090
AMOXICILLIN
Abbreviated New Drug Application
Approval
062337
DOXYCYCLINE HYCLATE
Abbreviated New Drug Application
Approval
062432
DOXYCYCLINE HYCLATE
Abbreviated New Drug Application
Approval
062847
ERYTHROMYCIN ETHYLSUCCINATE
Abbreviated New Drug Application
Approval
065195
CLARITHROMYCIN
Abbreviated New Drug Application
Approval
065360
AZITHROMYCIN
Abbreviated New Drug Application
Approval
065365
AZITHROMYCIN
Abbreviated New Drug Application
Approval
065366
AZITHROMYCIN
Abbreviated New Drug Application
Approval
065377
DOXYCYCLINE
Abbreviated New Drug Application
Approval
065427
DOXYCYCLINE
Abbreviated New Drug Application
Approval
065520
MYCOPHENOLATE MOFETIL
Abbreviated New Drug Application
Approval
065521
MYCOPHENOLATE MOFETIL
Abbreviated New Drug Application
Approval
070045
IBUPROFEN
Abbreviated New Drug Application
Approval
070057
IBUPROFEN
Abbreviated New Drug Application
Approval
070075
METHYLDOPA
Abbreviated New Drug Application
Approval
070076
METHYLDOPA
Abbreviated New Drug Application
Approval
070082
FUROSEMIDE
Abbreviated New Drug Application
Approval
070138
DISOPYRAMIDE PHOSPHATE
Abbreviated New Drug Application
Approval
070139
DISOPYRAMIDE PHOSPHATE
Abbreviated New Drug Application
Approval
070213
PROPRANOLOL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
070265
METHYLDOPA AND HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
070278
HALOPERIDOL
Abbreviated New Drug Application
Approval
070317
CLONIDINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
070325
DIAZEPAM
Abbreviated New Drug Application
Approval
070336
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
070337
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
070338
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
070624
INDOMETHACIN
Abbreviated New Drug Application
Approval
070790
DOXEPIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
070792
DOXEPIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
070793
DOXEPIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
070920
TEMAZEPAM
Abbreviated New Drug Application
Approval
070947
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
071081
MECLOFENAMATE SODIUM
Abbreviated New Drug Application
Approval
071093
THIOTHIXENE
Abbreviated New Drug Application
Approval
071296
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
071325
CLORPRES
Abbreviated New Drug Application
Approval
071405
TRAZODONE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
071406
TRAZODONE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
071442
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
071443
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
071483
VERAPAMIL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
071509
CLORAZEPATE DIPOTASSIUM
Abbreviated New Drug Application
Approval
071510
CLORAZEPATE DIPOTASSIUM
Abbreviated New Drug Application
Approval
071511
CLORAZEPATE DIPOTASSIUM
Abbreviated New Drug Application
Approval
071589
LORAZEPAM
Abbreviated New Drug Application
Approval
071590
LORAZEPAM
Abbreviated New Drug Application
Approval
071591
LORAZEPAM
Abbreviated New Drug Application
Approval
071713
OXAZEPAM
Abbreviated New Drug Application
Approval
071714
OXAZEPAM
Abbreviated New Drug Application
Approval
071715
OXAZEPAM
Abbreviated New Drug Application
Approval
071858
CLORAZEPATE DIPOTASSIUM
Abbreviated New Drug Application
Approval
071870
IBUPROFEN
Abbreviated New Drug Application
Approval
071999
IBUPROFEN
Abbreviated New Drug Application
Approval
072195
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
Abbreviated New Drug Application
Approval
072275
PROPRANOLOL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
072285
MAPROTILINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
072573
PRAZOSIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
072574
PRAZOSIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
072575
PRAZOSIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
072668
TIMOLOL MALEATE
Abbreviated New Drug Application
Approval
072741
LOPERAMIDE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
072838
DILTIAZEM HYDROCHLORIDE
Abbreviated New Drug Application
Approval
072894
ALBUTEROL SULFATE
Abbreviated New Drug Application
Approval
073038
SULINDAC
Abbreviated New Drug Application
Approval
073039
SULINDAC
Abbreviated New Drug Application
Approval
073209
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
073393
TOLMETIN SODIUM
Abbreviated New Drug Application
Approval
073457
ATENOLOL
Abbreviated New Drug Application
Approval
073466
GEMFIBROZIL
Abbreviated New Drug Application
Approval
073666
METOPROLOL TARTRATE
Abbreviated New Drug Application
Approval
074023
RANITIDINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
074035
KETOPROFEN
Abbreviated New Drug Application
Approval
074043
PIROXICAM
Abbreviated New Drug Application
Approval
074102
PIROXICAM
Abbreviated New Drug Application
Approval
074121
NAPROXEN
Abbreviated New Drug Application
Approval
074126
ATENOLOL
Abbreviated New Drug Application
Approval
074172
NADOLOL
Abbreviated New Drug Application
Approval
074203
ATENOLOL AND CHLORTHALIDONE
Abbreviated New Drug Application
Approval
074215
ALPRAZOLAM
Abbreviated New Drug Application
Approval
074226
GLIPIZIDE
Abbreviated New Drug Application
Approval
074234
NORTRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
074246
CIMETIDINE
Abbreviated New Drug Application
Approval
074288
ACEBUTOLOL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
074358
FLURBIPROFEN
Abbreviated New Drug Application
Approval
074367
NAPROXEN SODIUM
Abbreviated New Drug Application
Approval
074425
PENTOXIFYLLINE
Abbreviated New Drug Application
Approval
074434
CAPTOPRIL
Abbreviated New Drug Application
Approval
074438
GLIPIZIDE
Abbreviated New Drug Application
Approval
074452
GEMFIBROZIL
Abbreviated New Drug Application
Approval
074461
INDAPAMIDE
Abbreviated New Drug Application
Approval
074473
TOLMETIN SODIUM
Abbreviated New Drug Application
Approval
074552
RANITIDINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
074587
VERAPAMIL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
074642
NICARDIPINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
074701
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
074727
ACYCLOVIR
Abbreviated New Drug Application
Approval
074732
TAMOXIFEN CITRATE
Abbreviated New Drug Application
Approval
074761
KETOROLAC TROMETHAMINE
Abbreviated New Drug Application
Approval
074792
GLYBURIDE (MICRONIZED)
Abbreviated New Drug Application
Approval
074796
GUANFACINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
074866
SELEGILINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
074896
CAPTOPRIL AND HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
074910
DILTIAZEM HYDROCHLORIDE
Abbreviated New Drug Application
Approval
074932
ETODOLAC
Abbreviated New Drug Application
Approval
074947
CLOMIPRAMINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
074967
NITROFURANTOIN
Abbreviated New Drug Application
Approval
074976
ACYCLOVIR
Abbreviated New Drug Application
Approval
074977
ACYCLOVIR
Abbreviated New Drug Application
Approval
075012
ETODOLAC
Abbreviated New Drug Application
Approval
075071
ETODOLAC
Abbreviated New Drug Application
Approval
075091
CARBIDOPA AND LEVODOPA
Abbreviated New Drug Application
Approval
075104
ETODOLAC
Abbreviated New Drug Application
Approval
075108
NIFEDIPINE
Abbreviated New Drug Application
Approval
075124
DILTIAZEM HYDROCHLORIDE
Abbreviated New Drug Application
Approval
075138
VERAPAMIL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
075140
TERAZOSIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
075150
CLONAZEPAM
Abbreviated New Drug Application
Approval
075161
TICLOPIDINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
075188
AMIODARONE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
075207
FLUOXETINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
075211
ACYCLOVIR
Abbreviated New Drug Application
Approval
075237
SOTALOL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
075272
BUSPIRONE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
075278
PACLITAXEL
Abbreviated New Drug Application
Approval
075316
TICLOPIDINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
075417
CLOZAPINE
Abbreviated New Drug Application
Approval
075451
LOVASTATIN
Abbreviated New Drug Application
Approval
075463
DICLOFENAC POTASSIUM
Abbreviated New Drug Application
Approval
075467
BUSPIRONE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
075472
ENALAPRIL MALEATE
Abbreviated New Drug Application
Approval
075480
ENALAPRIL MALEATE
Abbreviated New Drug Application
Approval
075491
BUPROPION HYDROCHLORIDE
Abbreviated New Drug Application
Approval
075497
RANITIDINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
075509
DOXAZOSIN MESYLATE
Abbreviated New Drug Application
Approval
075564
RANITIDINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
075568
AZATHIOPRINE
Abbreviated New Drug Application
Approval
075597
KETOCONAZOLE
Abbreviated New Drug Application
Approval
075624
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
075635
ETOPOSIDE
Abbreviated New Drug Application
Approval
075640
HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
075674
FAMOTIDINE
Abbreviated New Drug Application
Approval
075679
KETOPROFEN
Abbreviated New Drug Application
Approval
075685
CIPROFLOXACIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
075704
FAMOTIDINE
Abbreviated New Drug Application
Approval
075725
SOTALOL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
075755
FLUOXETINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
075759
BUTORPHANOL TARTRATE
Abbreviated New Drug Application
Approval
075768
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
075790
LORATADINE
Abbreviated New Drug Application
Approval
075800
ETIDRONATE DISODIUM
Abbreviated New Drug Application
Approval
075817
CIPROFLOXACIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
075831
BISOPROLOL FUMARATE
Abbreviated New Drug Application
Approval
075851
OXAPROZIN
Abbreviated New Drug Application
Approval
075876
OMEPRAZOLE
Abbreviated New Drug Application
Approval
075889
FLUVOXAMINE MALEATE
Abbreviated New Drug Application
Approval
075935
LOVASTATIN
Abbreviated New Drug Application
Approval
075950
FLUVOXAMINE MALEATE
Abbreviated New Drug Application
Approval
075973
METFORMIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
075976
METFORMIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
075986
TRAMADOL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
076008
BUSPIRONE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
076036
QUINAPRIL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
076071
LISINOPRIL
Abbreviated New Drug Application
Approval
076113
LISINOPRIL AND HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
076122
MIRTAZAPINE
Abbreviated New Drug Application
Approval
076129
NEFAZODONE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
076152
DICLOFENAC SODIUM
Abbreviated New Drug Application
Approval
076154
LORATADINE
Abbreviated New Drug Application
Approval
076187
LEVOTHYROXINE SODIUM
Abbreviated New Drug Application
Approval
076224
FLUTAMIDE
Abbreviated New Drug Application
Approval
076276
LEVOFLOXACIN
Abbreviated New Drug Application
Approval
076288
RISPERIDONE
Abbreviated New Drug Application
Approval
076314
TOPIRAMATE
Abbreviated New Drug Application
Approval
076351
FLUCONAZOLE
Abbreviated New Drug Application
Approval
076354
TIZANIDINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
076418
AMLODIPINE BESYLATE
Abbreviated New Drug Application
Approval
076430
BENAZEPRIL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
076520
FENOFIBRATE
Abbreviated New Drug Application
Approval
076538
FEXOFENADINE HCL; PSEUDOEPHEDRINE HCL
Abbreviated New Drug Application
Tentative Approval
076578
ZOLPIDEM TARTRATE
Abbreviated New Drug Application
Approval
076584
ALENDRONATE SODIUM
Abbreviated New Drug Application
Approval
076630
LAMOTRIGINE
Abbreviated New Drug Application
Approval
076648
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
Abbreviated New Drug Application
Approval
076650
METFORMIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
076671
SERTRALINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
076677
CETIRIZINE HYDROCHLORIDE ALLERGY
CETIRIZINE HYDROCHLORIDE HIVES
Abbreviated New Drug Application
Approval
076688
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
076694
QUINAPRIL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
076698
METOLAZONE
Abbreviated New Drug Application
Approval
076702
OXYBUTYNIN CHLORIDE
Abbreviated New Drug Application
Approval
076704
METOPROLOL TARTRATE
Abbreviated New Drug Application
Approval
076762
LOXAPINE SUCCINATE
Abbreviated New Drug Application
Approval
076764
LEVOTHYROXINE SODIUM
Abbreviated New Drug Application
Approval
076792
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
076811
ANAGRELIDE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
076866
OLANZAPINE
Abbreviated New Drug Application
Approval
076919
LEVETIRACETAM
Abbreviated New Drug Application
Approval
076930
ONDANSETRON HYDROCHLORIDE
Abbreviated New Drug Application
Approval
076962
BROMOCRIPTINE MESYLATE
Abbreviated New Drug Application
Approval
077013
PRAVASTATIN SODIUM
Abbreviated New Drug Application
Approval
077025
NITROFURANTOIN
Abbreviated New Drug Application
Approval
077039
CITALOPRAM HYDROBROMIDE
Abbreviated New Drug Application
Approval
077042
CITALOPRAM HYDROBROMIDE
Abbreviated New Drug Application
Approval
077081
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES
FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDE ALLERGY
FEXOFENADINE HYDROCHLORIDE HIVES
Abbreviated New Drug Application
Approval
077093
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
077097
LEVOFLOXACIN
Abbreviated New Drug Application
Approval
077113
METFORMIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
077121
BACLOFEN
Abbreviated New Drug Application
Approval
077136
TERBINAFINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
077163
SUMATRIPTAN SUCCINATE
Abbreviated New Drug Application
Approval
077166
VENLAFAXINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
077181
BACLOFEN
Abbreviated New Drug Application
Approval
077195
TERBINAFINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
077226
BROMOCRIPTINE MESYLATE
Abbreviated New Drug Application
Approval
077238
ZALEPLON
Abbreviated New Drug Application
Approval
077254
DIVALPROEX SODIUM
Abbreviated New Drug Application
Approval
077316
CARVEDILOL
Abbreviated New Drug Application
Approval
077323
CILOSTAZOL
Abbreviated New Drug Application
Approval
077375
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
077391
ALPRAZOLAM
Abbreviated New Drug Application
Approval
077420
LAMOTRIGINE
Abbreviated New Drug Application
Approval
077428
LAMOTRIGINE
Abbreviated New Drug Application
Approval
077486
GLIMEPIRIDE
Abbreviated New Drug Application
Approval
077567
DIVALPROEX SODIUM
Abbreviated New Drug Application
Approval
077578
FINASTERIDE
Abbreviated New Drug Application
Approval
077590
GALANTAMINE HYDROBROMIDE
Abbreviated New Drug Application
Approval
077603
GALANTAMINE HYDROBROMIDE
Abbreviated New Drug Application
Approval
077616
SOTALOL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
077624
GLIMEPIRIDE
Abbreviated New Drug Application
Approval
077637
ZONISAMIDE
Abbreviated New Drug Application
Approval
077657
LORAZEPAM
Abbreviated New Drug Application
Approval
077705
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
077744
SUMATRIPTAN SUCCINATE
Abbreviated New Drug Application
Approval
077807
BALSALAZIDE DISODIUM
Abbreviated New Drug Application
Approval
077854
PRAMIPEXOLE DIHYDROCHLORIDE
Abbreviated New Drug Application
Approval
077858
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Abbreviated New Drug Application
Approval
077873
PAROXETINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
077923
MELOXICAM
Abbreviated New Drug Application
Approval
077934
MELOXICAM
Abbreviated New Drug Application
Approval
078022
PROPRANOLOL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
078045
FLUOXETINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
078070
VALACYCLOVIR HYDROCHLORIDE
Abbreviated New Drug Application
Approval
078083
GLIPIZIDE AND METFORMIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
078092
ALBUTEROL SULFATE
Abbreviated New Drug Application
Approval
078139
ONDANSETRON
Abbreviated New Drug Application
Approval
078190
LETROZOLE
Abbreviated New Drug Application
Approval
078306
VERAPAMIL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
078346
TRANDOLAPRIL
Abbreviated New Drug Application
Approval
078418
TOPIRAMATE
Abbreviated New Drug Application
Approval
078447
LORATADINE
Abbreviated New Drug Application
Approval
078638
ALENDRONATE SODIUM
Abbreviated New Drug Application
Approval
078688
NADOLOL AND BENDROFLUMETHIAZIDE
Abbreviated New Drug Application
Approval
078725
GRANISETRON HYDROCHLORIDE
Abbreviated New Drug Application
Approval
078731
LEVETIRACETAM
Abbreviated New Drug Application
Approval
078789
VENLAFAXINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
078855
FELODIPINE
Abbreviated New Drug Application
Approval
078881
ROPINIROLE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
078893
CARBIDOPA AND LEVODOPA
Abbreviated New Drug Application
Approval
078902
PAROXETINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
078915
POLYETHYLENE GLYCOL 3350
Abbreviated New Drug Application
Approval
079014
ALFUZOSIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
079047
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
079051
NISOLDIPINE
Abbreviated New Drug Application
Approval
079069
STAVUDINE
Abbreviated New Drug Application
Approval
079185
BICALUTAMIDE
Abbreviated New Drug Application
Approval
081235
METHOTREXATE SODIUM
Abbreviated New Drug Application
Approval
083299
PROPOXYPHENE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
083528
PROPOXYPHENE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
083618
MEPROBAMATE
Abbreviated New Drug Application
Approval
083689
PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN
Abbreviated New Drug Application
Approval
083706
PROPANTHELINE BROMIDE
Abbreviated New Drug Application
Approval
083978
PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN
Abbreviated New Drug Application
Approval
084211
PROBENECID
Abbreviated New Drug Application
Approval
084217
CHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
084259
METHOCARBAMOL
Abbreviated New Drug Application
Approval
084323
METHOCARBAMOL
Abbreviated New Drug Application
Approval
084388
CHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
084406
TRIAMCINOLONE
Abbreviated New Drug Application
Approval
084601
CHLORDIAZEPOXIDE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
084880
HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
084886
CHLORDIAZEPOXIDE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
084887
CHLORDIAZEPOXIDE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
084974
RESERPINE
Abbreviated New Drug Application
Approval
085112
HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
085762
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
Abbreviated New Drug Application
Approval
086009
AMITRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
086010
AMITRIPTYLINE HYDROCHLORIDE
New Drug Application
Approval
086011
AMITRIPTYLINE HYDROCHLORIDE
New Drug Application
Approval
086153
AMITRIPTYLINE HYDROCHLORIDE
New Drug Application
Approval
086157
AMITRIPTYLINE HYDROCHLORIDE
New Drug Application
Approval
086158
AMITRIPTYLINE HYDROCHLORIDE
New Drug Application
Approval
086513
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
086678
CYPROHEPTADINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
086831
CHLORTHALIDONE
Abbreviated New Drug Application
Approval
087085
HYDRALAZINE HYDROCHLORIDE-HYDROCHLOROTHIAZIDE-RESERPINE
Abbreviated New Drug Application
Approval
087086
SPIRONOLACTONE
Abbreviated New Drug Application
Approval
087671
METHYCLOTHIAZIDE
Abbreviated New Drug Application
Approval
087744
CHLOROTHIAZIDE-RESERPINE
Abbreviated New Drug Application
Approval
087745
CHLOROTHIAZIDE-RESERPINE
Abbreviated New Drug Application
Approval
088004
THIORIDAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088332
THIORIDAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088333
THIORIDAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088334
THIORIDAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088335
THIORIDAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088549
CHLORPROPAMIDE
Abbreviated New Drug Application
Approval
089804
FLUPHENAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
090062
DIVALPROEX SODIUM
Abbreviated New Drug Application
Approval
090158
GABAPENTIN
Abbreviated New Drug Application
Approval
090261
LEVETIRACETAM
Abbreviated New Drug Application
Approval
090324
CARBIDOPA AND LEVODOPA
Abbreviated New Drug Application
Approval
090325
BUPROPION HYDROCHLORIDE
Abbreviated New Drug Application
Approval
090326
LIOTHYRONINE SODIUM
Abbreviated New Drug Application
Approval
090406
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
090407
DIVALPROEX SODIUM
Abbreviated New Drug Application
Approval
090408
TAMSULOSIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
090409
PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE
Abbreviated New Drug Application
Approval
090410
BUDESONIDE
Abbreviated New Drug Application
Approval
090413
HYDRALAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
090431
DOXYCYCLINE HYCLATE
Abbreviated New Drug Application
Approval
090530
URSODIOL
Abbreviated New Drug Application
Approval
090596
TACROLIMUS
Abbreviated New Drug Application
Approval
090649
NIFEDIPINE
Abbreviated New Drug Application
Approval
090764
PRAMIPEXOLE DIHYDROCHLORIDE
Abbreviated New Drug Application
Approval
090855
DOXYCYCLINE
Abbreviated New Drug Application
Tentative Approval
090900
GALANTAMINE HYDROBROMIDE
Abbreviated New Drug Application
Approval
090928
PEG 3350 AND ELECTROLYTES
Abbreviated New Drug Application
Approval
090941
BUPROPION HYDROCHLORIDE
Abbreviated New Drug Application
Approval
090942
BUPROPION HYDROCHLORIDE
Abbreviated New Drug Application
Approval
091001
NISOLDIPINE
Abbreviated New Drug Application
Approval
091051
ANASTROZOLE
Abbreviated New Drug Application
Approval
091053
ACARBOSE
Abbreviated New Drug Application
Approval
091054
PROMETHAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
091176
HYDROXYZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
091427
PAROXETINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
091590
LOSARTAN POTASSIUM
Abbreviated New Drug Application
Approval
091652
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
201071
NIFEDIPINE
Abbreviated New Drug Application
Approval
201333
FAMCICLOVIR
Abbreviated New Drug Application
Approval
201786
LATANOPROST
Abbreviated New Drug Application
Approval
204475
FENOFIBRATE
Abbreviated New Drug Application
Approval
205133
TRANEXAMIC ACID
Abbreviated New Drug Application
Approval
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