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Back to Companies who have applied for FDA Drug Approval
FDA Drug Approval Applications Sponsored by SUN PHARM INDS
Application Number
Drugs/Products
Application Type
Most Recent Label Available Flag
Current Patent Flag
Action Type
Chemical Type
Ther Potential
Orphan Code
011483
SYNALGOS-DC
New Drug Application
Approval
New combination
(S) Standard review drug
017377
BACTRIM
BACTRIM DS
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017560
BACTRIM
BACTRIM PEDIATRIC
New Drug Application
Approval
New formulation
(S) Standard review drug
021799
QUALAQUIN
New Drug Application
Approval
New manufacturer
(S) Standard review drug
040260
OXYCODONE AND ASPIRIN
Abbreviated New Drug Application
Approval
040480
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Abbreviated New Drug Application
Approval
040525
PHENTERMINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
040526
PHENTERMINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
040527
PHENTERMINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
040582
FOLIC ACID
Abbreviated New Drug Application
Approval
040601
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Abbreviated New Drug Application
Approval
040731
EXTENDED PHENYTOIN SODIUM
Abbreviated New Drug Application
Approval
060736
TETRACYCLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
062676
DOXYCYCLINE HYCLATE
Abbreviated New Drug Application
Approval
062677
DOXYCYCLINE HYCLATE
Abbreviated New Drug Application
Approval
062838
NYSTATIN
Abbreviated New Drug Application
Approval
065134
DOXYCYCLINE HYCLATE
Abbreviated New Drug Application
Approval
065471
DOXYCYCLINE
Abbreviated New Drug Application
Approval
070043
FUROSEMIDE
Abbreviated New Drug Application
Approval
070060
METHYLDOPA
Abbreviated New Drug Application
Approval
070073
METHYLDOPA
Abbreviated New Drug Application
Approval
070074
METHYLDOPA
Abbreviated New Drug Application
Approval
070079
IBUPROFEN
Abbreviated New Drug Application
Approval
070080
IBUPROFEN
Abbreviated New Drug Application
Approval
070100
FUROSEMIDE
Abbreviated New Drug Application
Approval
070270
NALIDIXIC ACID
Abbreviated New Drug Application
Approval
070271
NALIDIXIC ACID
Abbreviated New Drug Application
Approval
070272
NALIDIXIC ACID
Abbreviated New Drug Application
Approval
070297
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
070351
DISOPYRAMIDE PHOSPHATE
Abbreviated New Drug Application
Approval
070352
DISOPYRAMIDE PHOSPHATE
Abbreviated New Drug Application
Approval
070454
FLURAZEPAM HYDROCHLORIDE
Abbreviated New Drug Application
Approval
070455
FLURAZEPAM HYDROCHLORIDE
Abbreviated New Drug Application
Approval
070493
IBUPROFEN
Abbreviated New Drug Application
Approval
070494
TRIMETHOPRIM
Abbreviated New Drug Application
Approval
070495
TRIMETHOPRIM
Abbreviated New Drug Application
Approval
070900
INDOMETHACIN
Abbreviated New Drug Application
Approval
070908
IBUPROFEN
Abbreviated New Drug Application
Approval
071017
SULFAMETHOXAZOLE AND TRIMETHOPRIM
Abbreviated New Drug Application
Approval
071026
OXAZEPAM
Abbreviated New Drug Application
Approval
071077
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
071078
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
071079
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
071174
TEMAZEPAM
Abbreviated New Drug Application
Approval
071175
TEMAZEPAM
Abbreviated New Drug Application
Approval
071177
HALOPERIDOL
Abbreviated New Drug Application
Approval
071357
TOLAZAMIDE
Abbreviated New Drug Application
Approval
071358
TOLAZAMIDE
Abbreviated New Drug Application
Approval
071359
TOLAZAMIDE
Abbreviated New Drug Application
Approval
071448
IBUPROFEN
Abbreviated New Drug Application
Approval
071450
ALLOPURINOL
Abbreviated New Drug Application
Approval
071462
IBUPROFEN
Abbreviated New Drug Application
Approval
071489
VERAPAMIL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
071502
DOXEPIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
071521
DOXEPIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
071536
METOCLOPRAMIDE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
071653
DOXEPIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
071654
DOXEPIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
072050
SULINDAC
Abbreviated New Drug Application
Approval
072051
SULINDAC
Abbreviated New Drug Application
Approval
072637
ALBUTEROL SULFATE
Abbreviated New Drug Application
Approval
072709
MINOXIDIL
Abbreviated New Drug Application
Approval
072902
FENOPROFEN CALCIUM
Abbreviated New Drug Application
Approval
073137
TRAZODONE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
073310
TOLMETIN SODIUM
Abbreviated New Drug Application
Approval
073311
TOLMETIN SODIUM
Abbreviated New Drug Application
Approval
073475
ATENOLOL
Abbreviated New Drug Application
Approval
073476
ATENOLOL
Abbreviated New Drug Application
Approval
073536
PIROXICAM
Abbreviated New Drug Application
Approval
073582
ATENOLOL AND CHLORTHALIDONE
Abbreviated New Drug Application
Approval
073654
METOPROLOL TARTRATE
Abbreviated New Drug Application
Approval
074063
PINDOLOL
Abbreviated New Drug Application
Approval
074499
ATENOLOL
Abbreviated New Drug Application
Approval
075314
KETOCONAZOLE
Abbreviated New Drug Application
Approval
075470
DICLOFENAC POTASSIUM
Abbreviated New Drug Application
Approval
075515
SOTALOL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
075639
FAMOTIDINE
Abbreviated New Drug Application
Approval
075787
FLUOXETINE
Abbreviated New Drug Application
Approval
075896
FELODIPINE
Abbreviated New Drug Application
Approval
075998
PROPAFENONE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
076038
METFORMIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
076100
TRAMADOL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
076125
FLUVOXAMINE MALEATE
Abbreviated New Drug Application
Approval
076537
GABAPENTIN
Abbreviated New Drug Application
Approval
076570
TRIMETHOBENZAMIDE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
076576
SOTALOL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
077052
CITALOPRAM HYDROBROMIDE
Abbreviated New Drug Application
Approval
077124
METFORMIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
077131
RIVASTIGMINE TARTRATE
Abbreviated New Drug Application
Approval
077212
DESMOPRESSIN ACETATE
Abbreviated New Drug Application
Approval
077288
ZOLPIDEM TARTRATE
Abbreviated New Drug Application
Approval
077329
OCTREOTIDE ACETATE
Abbreviated New Drug Application
Approval
077330
OCTREOTIDE ACETATE
Abbreviated New Drug Application
Approval
077331
OCTREOTIDE ACETATE
Abbreviated New Drug Application
Approval
077372
OCTREOTIDE ACETATE
Abbreviated New Drug Application
Approval
077373
OCTREOTIDE ACETATE
Abbreviated New Drug Application
Approval
077520
LOVASTATIN
Abbreviated New Drug Application
Approval
077555
TIAGABINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
077557
ONDANSETRON
Abbreviated New Drug Application
Approval
077592
GALANTAMINE HYDROBROMIDE
Abbreviated New Drug Application
Tentative Approval
077635
ZONISAMIDE
Abbreviated New Drug Application
Approval
077794
OXCARBAZEPINE
Abbreviated New Drug Application
Approval
077828
CARBIDOPA AND LEVODOPA
Abbreviated New Drug Application
Approval
077975
DONEPEZIL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
078081
AMLODIPINE BESYLATE
Abbreviated New Drug Application
Approval
078133
CLOPIDOGREL BISULFATE
Abbreviated New Drug Application
Approval
078295
SUMATRIPTAN SUCCINATE
Abbreviated New Drug Application
Approval
078359
DESLORATADINE
Abbreviated New Drug Application
Approval
078478
TORSEMIDE
Abbreviated New Drug Application
Approval
078536
CARBIDOPA AND LEVODOPA
Abbreviated New Drug Application
Approval
078581
TEMAZEPAM
Abbreviated New Drug Application
Approval
078597
DIVALPROEX SODIUM
Abbreviated New Drug Application
Approval
078996
IBANDRONATE SODIUM
Abbreviated New Drug Application
Approval
080136
ISONIAZID
Abbreviated New Drug Application
Approval
080448
MEPERIDINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
080699
MEPROBAMATE
Abbreviated New Drug Application
Approval
080700
CHLORPHENIRAMINE MALEATE
Abbreviated New Drug Application
Approval
081029
QUINIDINE SULFATE
Abbreviated New Drug Application
Approval
081030
QUINIDINE SULFATE
Abbreviated New Drug Application
Approval
081031
QUINIDINE SULFATE
Abbreviated New Drug Application
Approval
081048
IMIPRAMINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
081049
IMIPRAMINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
081050
IMIPRAMINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
081113
ERGOLOID MESYLATES
Abbreviated New Drug Application
Approval
083633
ISONIAZID
Abbreviated New Drug Application
Approval
083972
HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
083982
PROPYLTHIOURACIL
Abbreviated New Drug Application
Approval
084013
DEXAMETHASONE
Abbreviated New Drug Application
Approval
084081
DEXAMETHASONE
Abbreviated New Drug Application
Approval
084084
DEXAMETHASONE
Abbreviated New Drug Application
Approval
084086
DEXAMETHASONE
Abbreviated New Drug Application
Approval
084204
ISOSORBIDE DINITRATE
Abbreviated New Drug Application
Approval
084486
METHOCARBAMOL
Abbreviated New Drug Application
Approval
084488
METHOCARBAMOL
Abbreviated New Drug Application
Approval
084505
DICYCLOMINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
084554
PROMETHAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
084555
PROMETHAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
084557
PROMETHAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
084600
DICYCLOMINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
084763
DEXAMETHASONE
Abbreviated New Drug Application
Approval
084764
DEXAMETHASONE
Abbreviated New Drug Application
Approval
084765
DEXAMETHASONE
Abbreviated New Drug Application
Approval
084766
DEXAMETHASONE
Abbreviated New Drug Application
Approval
085506
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
Abbreviated New Drug Application
Approval
086166
ISOSORBIDE DINITRATE
Abbreviated New Drug Application
Approval
086167
ISOSORBIDE DINITRATE
Abbreviated New Drug Application
Approval
086168
ISOSORBIDE DINITRATE
Abbreviated New Drug Application
Approval
086169
ISOSORBIDE DINITRATE
Abbreviated New Drug Application
Approval
086596
PREDNISONE
Abbreviated New Drug Application
Approval
087407
ERGOLOID MESYLATES
Abbreviated New Drug Application
Approval
087545
ISOSORBIDE DINITRATE
Abbreviated New Drug Application
Approval
087552
ERGOLOID MESYLATES
Abbreviated New Drug Application
Approval
087564
ISOSORBIDE DINITRATE
Abbreviated New Drug Application
Approval
087794
OXYCODONE AND ASPIRIN
Abbreviated New Drug Application
Approval
087862
HYDROXYZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088461
THIORIDAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088570
RESERPINE, HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
088737
THIORIDAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088738
THIORIDAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088863
PHENYLBUTAZONE
Abbreviated New Drug Application
Approval
088994
PHENYLBUTAZONE
Abbreviated New Drug Application
Approval
089247
PREDNISONE
Abbreviated New Drug Application
Approval
089286
CHLORTHALIDONE
Abbreviated New Drug Application
Approval
089338
QUINIDINE GLUCONATE
Abbreviated New Drug Application
Approval
089346
CARISOPRODOL
Abbreviated New Drug Application
Approval
089381
HYDROXYZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
089382
HYDROXYZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
089383
HYDROXYZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
089424
SPIRONOLACTONE
Abbreviated New Drug Application
Approval
089488
DIPHENHYDRAMINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
089489
DIPHENHYDRAMINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
089534
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
089590
SULFASALAZINE
Abbreviated New Drug Application
Approval
089753
ACETAZOLAMIDE
Abbreviated New Drug Application
Approval
089953
THIORIDAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
089970
CHLORZOXAZONE
Abbreviated New Drug Application
Approval
090217
MINOCYCLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
090493
DONEPEZIL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
090654
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
090881
OLANZAPINE
Abbreviated New Drug Application
Approval
091038
OLANZAPINE
Abbreviated New Drug Application
Approval
091285
LEVETIRACETAM
Abbreviated New Drug Application
Approval
091418
DOXORUBICIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
091567
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES
FEXOFENADINE HYDROCHLORIDE ALLERGY
FEXOFENADINE HYDROCHLORIDE HIVES
Abbreviated New Drug Application
Approval
091626
EPINASTINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
201231
DEXMETHYLPHENIDATE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
201722
NITROFURANTOIN
Abbreviated New Drug Application
Approval
208183
ULTRAVATE
New Drug Application
Approval
New formulation
(S) Standard review drug
Back to Companies who have applied for FDA Drug Approval