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Back to Companies who have applied for FDA Drug Approval
FDA Drug Approval Applications Sponsored by MYLAN PHARMS INC
Application Number
Drugs/Products
Application Type
Most Recent Label Available Flag
Current Patent Flag
Action Type
Chemical Type
Ther Potential
Orphan Code
019129
MAXZIDE
MAXZIDE-25
New Drug Application
Approval
New formulation
(P) Priority review drug
020404
AVITA
New Drug Application
Approval
New manufacturer
(S) Standard review drug
040282
DIGOXIN
Abbreviated New Drug Application
Approval
040735
HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
040770
HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
065443
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
Abbreviated New Drug Application
Approval
070145
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
Abbreviated New Drug Application
Approval
070259
TOLAZAMIDE
Abbreviated New Drug Application
Approval
070345
FLURAZEPAM HYDROCHLORIDE
Abbreviated New Drug Application
Approval
070791
DOXEPIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
071297
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
072267
FENOPROFEN CALCIUM
Abbreviated New Drug Application
Approval
073144
CYCLOBENZAPRINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
074013
PINDOLOL
Abbreviated New Drug Application
Approval
074018
PINDOLOL
Abbreviated New Drug Application
Approval
074019
PINDOLOL
Abbreviated New Drug Application
Approval
074031
TRIAZOLAM
Abbreviated New Drug Application
Approval
074046
ALPRAZOLAM
Abbreviated New Drug Application
Approval
074940
CLONAZEPAM
Abbreviated New Drug Application
Approval
075105
INDAPAMIDE
Abbreviated New Drug Application
Approval
075281
DICLOFENAC SODIUM
Abbreviated New Drug Application
Approval
075390
NAPROXEN
Abbreviated New Drug Application
Approval
075457
FAMOTIDINE
Abbreviated New Drug Application
Approval
075577
FLUOXETINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
075716
PAROXETINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
075806
NIZATIDINE
Abbreviated New Drug Application
Approval
075847
OXAPROZIN
Abbreviated New Drug Application
Approval
075934
NIZATIDINE
Abbreviated New Drug Application
Approval
075945
AMNESTEEM
Abbreviated New Drug Application
Approval
075969
METFORMIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
075980
TRAMADOL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
076042
FLUCONAZOLE
Abbreviated New Drug Application
Approval
076176
MIRTAZAPINE
Abbreviated New Drug Application
Approval
076282
TIZANIDINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
076540
SERTRALINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
076577
MIDODRINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
076594
MODAFINIL
Abbreviated New Drug Application
Approval
076612
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
076644
OXYBUTYNIN CHLORIDE
Abbreviated New Drug Application
Approval
076801
PIOGLITAZONE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
076885
RABEPRAZOLE SODIUM
Abbreviated New Drug Application
Approval
077019
CILOSTAZOL
Abbreviated New Drug Application
Approval
077037
CITALOPRAM HYDROBROMIDE
Abbreviated New Drug Application
Approval
077550
ESCITALOPRAM OXALATE
Abbreviated New Drug Application
Approval
077613
ANAGRELIDE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
077647
ZONISAMIDE
Abbreviated New Drug Application
Approval
077660
ESCITALOPRAM OXALATE
Abbreviated New Drug Application
Approval
077665
CLOPIDOGREL BISULFATE
Abbreviated New Drug Application
Approval
077668
CITALOPRAM HYDROBROMIDE
Abbreviated New Drug Application
Approval
077969
IRBESARTAN AND HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
078016
ZOLPIDEM TARTRATE
Abbreviated New Drug Application
Approval
078020
VALSARTAN AND HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
078161
FINASTERIDE
Abbreviated New Drug Application
Approval
078173
RIZATRIPTAN BENZOATE
Abbreviated New Drug Application
Approval
078183
CIPROFLOXACIN EXTENDED RELEASE
Abbreviated New Drug Application
Approval
078224
AMLODIPINE BESYLATE
Abbreviated New Drug Application
Approval
078276
OLMESARTAN MEDOXOMIL
Abbreviated New Drug Application
Approval
078293
Oxybutynin Chloride
New Drug Application
Approval
078351
DESLORATADINE
Abbreviated New Drug Application
Approval
078518
VALACYCLOVIR HYDROCHLORIDE
Abbreviated New Drug Application
Approval
078567
CICLOPIROX
Abbreviated New Drug Application
Approval
078626
SERTRALINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
078743
MALATHION
Abbreviated New Drug Application
Approval
078827
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
078845
LINEZOLID
Abbreviated New Drug Application
Approval
078857
CELECOXIB
Abbreviated New Drug Application
Approval
078922
ZIDOVUDINE
Abbreviated New Drug Application
Approval
078936
ESOMEPRAZOLE MAGNESIUM
Abbreviated New Drug Application
Approval
078995
IBANDRONATE SODIUM
Abbreviated New Drug Application
Approval
079021
ATOMOXETINE HYDROCHLORIDE
Abbreviated New Drug Application
Tentative Approval
079103
MONTELUKAST SODIUM
Abbreviated New Drug Application
Approval
079142
MONTELUKAST SODIUM
Abbreviated New Drug Application
Approval
079161
ROSUVASTATIN CALCIUM
Abbreviated New Drug Application
Approval
079187
PRAVASTATIN SODIUM
Abbreviated New Drug Application
Approval
079225
MEMANTINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
086445
TOLBUTAMIDE
Abbreviated New Drug Application
Approval
087672
METHYCLOTHIAZIDE
Abbreviated New Drug Application
Approval
090252
REPAGLINIDE
Abbreviated New Drug Application
Approval
090323
QUETIAPINE FUMARATE
Abbreviated New Drug Application
Approval
090334
BACLOFEN
Abbreviated New Drug Application
Approval
090335
GABAPENTIN
Abbreviated New Drug Application
Approval
090483
AMLODIPINE BESYLATE AND VALSARTAN
Abbreviated New Drug Application
Approval
090514
TRAZODONE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
090516
NABUMETONE
Abbreviated New Drug Application
Approval
090521
DONEPEZIL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
090547
VORICONAZOLE
Abbreviated New Drug Application
Approval
090595
FLUVASTATIN SODIUM
Abbreviated New Drug Application
Approval
090650
RAMIPRIL
Abbreviated New Drug Application
Approval
090763
LANSOPRAZOLE
Abbreviated New Drug Application
Approval
090788
DIDANOSINE
Abbreviated New Drug Application
Approval
090868
SIMVASTATIN
Abbreviated New Drug Application
Approval
090872
SUMATRIPTAN SUCCINATE; NAPROXEN SODIUM
Abbreviated New Drug Application
Tentative Approval
090911
MINOCYCLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
090943
CAPECITABINE
Abbreviated New Drug Application
Approval
090970
PANTOPRAZOLE SODIUM
Abbreviated New Drug Application
Approval
091002
ERLOTINIB HYDROCHLORIDE
Abbreviated New Drug Application
Approval
091052
DOXYCYCLINE HYCLATE
Abbreviated New Drug Application
Approval
091151
ESZOPICLONE
Abbreviated New Drug Application
Approval
091225
CLINDAMYCIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
091226
ATORVASTATIN CALCIUM
Abbreviated New Drug Application
Approval
091228
PREGABALIN
Abbreviated New Drug Application
Tentative Approval
091248
MYCOPHENOLIC ACID
Abbreviated New Drug Application
Approval
091294
ABACAVIR SULFATE
Abbreviated New Drug Application
Approval
091471
EFAVIRENZ
Abbreviated New Drug Application
Approval
091502
TIZANIDINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
091537
RISPERIDONE
Abbreviated New Drug Application
Approval
091648
TELMISARTAN AND HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
200043
ARMODAFINIL
Abbreviated New Drug Application
Approval
200142
ACAMPROSATE CALCIUM
Abbreviated New Drug Application
Approval
200461
IRBESARTAN
Abbreviated New Drug Application
Approval
200462
ROPINIROLE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
200463
ITRACONAZOLE
Abbreviated New Drug Application
Approval
200465
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Abbreviated New Drug Application
Approval
200475
LEVETIRACETAM
Abbreviated New Drug Application
Approval
200477
RISEDRONATE SODIUM
Abbreviated New Drug Application
Approval
200579
FENOFIBRATE
Abbreviated New Drug Application
Tentative Approval
200653
DESMOPRESSIN ACETATE
Abbreviated New Drug Application
Approval
200690
METFORMIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
200691
PHENYTOIN
Abbreviated New Drug Application
Approval
200824
MORPHINE SULFATE
Abbreviated New Drug Application
Approval
200913
FENOFIBRIC ACID
Abbreviated New Drug Application
Approval
200915
CYTARABINE
Abbreviated New Drug Application
Approval
200916
CYTARABINE
Abbreviated New Drug Application
Approval
201066
BUPRENORPHINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
201067
ISRADIPINE
Abbreviated New Drug Application
Approval
201150
SILDENAFIL CITRATE
Abbreviated New Drug Application
Approval
201275
SUNITINIB MALATE
Abbreviated New Drug Application
Tentative Approval
201486
TOLTERODINE TARTRATE
Abbreviated New Drug Application
Approval
201790
EZETIMIBE
Abbreviated New Drug Application
Tentative Approval
201824
CLOZAPINE
Abbreviated New Drug Application
Approval
201993
RIZATRIPTAN BENZOATE
Abbreviated New Drug Application
Approval
202012
EPROSARTAN MESYLATE
Abbreviated New Drug Application
Approval
202019
VARENICLINE
Abbreviated New Drug Application
Tentative Approval
202033
METOPROLOL SUCCINATE
Abbreviated New Drug Application
Approval
202136
DARUNAVIR
Abbreviated New Drug Application
Tentative Approval
202139
INDOMETHACIN
Abbreviated New Drug Application
Approval
202148
ACITRETIN
Abbreviated New Drug Application
Approval
202179
PREDNISOLONE SODIUM PHOSPHATE
Abbreviated New Drug Application
Approval
202219
LITHIUM CARBONATE
Abbreviated New Drug Application
Approval
202228
QUETIAPINE FUMARATE
Abbreviated New Drug Application
Tentative Approval
202285
OLANZAPINE
Abbreviated New Drug Application
Approval
202288
LITHIUM CARBONATE
Abbreviated New Drug Application
Approval
202298
GLIPIZIDE
Abbreviated New Drug Application
Approval
202337
DOXEPIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
202338
IMIPRAMINE PAMOATE
Abbreviated New Drug Application
Approval
202361
VORICONAZOLE
Abbreviated New Drug Application
Approval
202362
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
202394
ENTACAPONE
Abbreviated New Drug Application
Approval
202395
ZIPRASIDONE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
202397
TELMISARTAN
Abbreviated New Drug Application
Approval
202431
NARATRIPTAN
Abbreviated New Drug Application
Approval
202458
FLUVASTATIN SODIUM
Abbreviated New Drug Application
Approval
202459
ACYCLOVIR
Abbreviated New Drug Application
Approval
202473
SITAGLIPTIN PHOSPHATE
Abbreviated New Drug Application
Tentative Approval
202516
TELMISARTAN AND AMLODIPINE
Abbreviated New Drug Application
Approval
202523
NEVIRAPINE
Abbreviated New Drug Application
Approval
202577
FENTANYL
Abbreviated New Drug Application
Tentative Approval
202578
GUANFACINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
202579
FENOFIBRATE (MICRONIZED)
Abbreviated New Drug Application
Approval
202580
DEXMETHYLPHENIDATE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
202581
QUININE SULFATE
Abbreviated New Drug Application
Approval
202640
MECLIZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
202641
TOLTERODINE TARTRATE
Abbreviated New Drug Application
Approval
202656
DONEPEZIL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
202657
ZOLPIDEM TARTRATE
Abbreviated New Drug Application
Approval
202676
FENOFIBRATE (MICRONIZED)
Abbreviated New Drug Application
Approval
202738
RITONAVIR
Abbreviated New Drug Application
Tentative Approval
202776
MONTELUKAST SODIUM
Abbreviated New Drug Application
Approval
202778
DOXYCYCLINE
Abbreviated New Drug Application
Approval
202835
LISDEXAMFETAMINE DIMESYLATE
Abbreviated New Drug Application
Tentative Approval
202856
FENOFIBRATE
Abbreviated New Drug Application
Approval
202931
FROVATRIPTAN SUCCINATE
Abbreviated New Drug Application
Approval
202947
CABERGOLINE
Abbreviated New Drug Application
Approval
203042
RILUZOLE
Abbreviated New Drug Application
Approval
203063
CLINDAMYCIN PALMITATE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
203186
ZOLMITRIPTAN
Abbreviated New Drug Application
Approval
203187
LANSOPRAZOLE
Abbreviated New Drug Application
Approval
203241
DUTASTERIDE
Abbreviated New Drug Application
Approval
203422
CINACALCET HYDROCHLORIDE
Abbreviated New Drug Application
Tentative Approval
203443
MINOCYCLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
203707
ACITRETIN
Abbreviated New Drug Application
Approval
203802
PALIPERIDONE
Abbreviated New Drug Application
Approval
203803
PROPAFENONE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
203916
DISULFIRAM
Abbreviated New Drug Application
Approval
204002
LAMIVUDINE
Abbreviated New Drug Application
Approval
204004
EPZICOM
Abbreviated New Drug Application
Tentative Approval
204005
LAMIVUDINE AND ZIDOVUDINE
Abbreviated New Drug Application
Approval
204060
FOSAMPRENAVIR CALCIUM
Abbreviated New Drug Application
Approval
204095
DESVENLAFAXINE SUCCINATE
Abbreviated New Drug Application
Approval
204266
DEXMETHYLPHENIDATE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
204354
MESALAMINE
Abbreviated New Drug Application
Approval
204528
LAMIVUDINE
Abbreviated New Drug Application
Approval
204635
MOXIFLOXACIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
204662
POTASSIUM CHLORIDE
Abbreviated New Drug Application
Approval
205026
LACOSAMIDE
Abbreviated New Drug Application
Approval
205050
TRAVOPROST
Abbreviated New Drug Application
Tentative Approval
205095
RUFINAMIDE
Abbreviated New Drug Application
Approval
205152
ELETRIPTAN HYDROBROMIDE
Abbreviated New Drug Application
Tentative Approval
205171
ALMOTRIPTAN MALATE
Abbreviated New Drug Application
Approval
205227
TEMOZOLOMIDE
Abbreviated New Drug Application
Approval
205257
TRAMADOL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
205367
MILNACIPRAN HYDROCHLORIDE
Abbreviated New Drug Application
Tentative Approval
205385
FEBUXOSTAT
Abbreviated New Drug Application
Tentative Approval
205651
NEVIRAPINE
Abbreviated New Drug Application
Approval
205927
PRASUGREL
Abbreviated New Drug Application
Approval
206032
MEMANTINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
206271
NEVIRAPINE
Abbreviated New Drug Application
Approval
206569
TENOFOVIR DISOPROXIL FUMARATE
Abbreviated New Drug Application
Tentative Approval
206721
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Abbreviated New Drug Application
Approval
206726
METHYLPHENIDATE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
206735
DEXTROAMPHETAMINE SULFATE
Abbreviated New Drug Application
Approval
206848
DALFAMPRIDINE
Abbreviated New Drug Application
Tentative Approval
206909
BALSALAZIDE DISODIUM
Abbreviated New Drug Application
Tentative Approval
207012
SORAFENIB
Abbreviated New Drug Application
Tentative Approval
Back to Companies who have applied for FDA Drug Approval