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Back to Companies who have applied for FDA Drug Approval
FDA Drug Approval Applications Sponsored by PAR PHARM
Application Number
Drugs/Products
Application Type
Most Recent Label Available Flag
Current Patent Flag
Action Type
Chemical Type
Ther Potential
Orphan Code
018343
CAPOTEN
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
018845
METRONIDAZOLE
New Drug Application
Approval
018930
METRONIDAZOLE
New Drug Application
Approval
019722
NASCOBAL
New Drug Application
Approval
New formulation
(S) Standard review drug
022102
CALOMIST
New Drug Application
Approval
New manufacturer
(S) Standard review drug
040357
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
Abbreviated New Drug Application
Approval
040640
TRANYLCYPROMINE SULFATE
Abbreviated New Drug Application
Approval
040653
GLYCOPYRROLATE
Abbreviated New Drug Application
Approval
060400
SUMYCIN
Abbreviated New Drug Application
Approval
061147
SUMYCIN
Abbreviated New Drug Application
Approval
062434
DOXYCYCLINE HYCLATE
Abbreviated New Drug Application
Approval
062442
DOXYCYCLINE HYCLATE
Abbreviated New Drug Application
Approval
065055
DOXYCYCLINE
Abbreviated New Drug Application
Approval
065070
DOXYCYCLINE
Abbreviated New Drug Application
Approval
065131
MINOCYCLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
070156
DOXY-SLEEP-AID
Abbreviated New Drug Application
Approval
070159
TOLAZAMIDE
Abbreviated New Drug Application
Approval
070160
TOLAZAMIDE
Abbreviated New Drug Application
Approval
070161
TOLAZAMIDE
Abbreviated New Drug Application
Approval
070328
IBUPROFEN
Abbreviated New Drug Application
Approval
070329
IBUPROFEN
Abbreviated New Drug Application
Approval
070330
IBUPROFEN
Abbreviated New Drug Application
Approval
070342
METOCLOPRAMIDE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
070346
AMILORIDE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
070347
HYDRO-RIDE
Abbreviated New Drug Application
Approval
070431
VALPROIC ACID
Abbreviated New Drug Application
Approval
070444
FLURAZEPAM HYDROCHLORIDE
Abbreviated New Drug Application
Approval
070445
FLURAZEPAM HYDROCHLORIDE
Abbreviated New Drug Application
Approval
070459
CLONIDINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
070460
CLONIDINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
070461
CLONIDINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
070462
DIAZEPAM
Abbreviated New Drug Application
Approval
070463
DIAZEPAM
Abbreviated New Drug Application
Approval
070464
DIAZEPAM
Abbreviated New Drug Application
Approval
070481
IBUPROFEN
Abbreviated New Drug Application
Approval
070535
METHYLDOPA
Abbreviated New Drug Application
Approval
070536
METHYLDOPA
Abbreviated New Drug Application
Approval
070537
METHYLDOPA
Abbreviated New Drug Application
Approval
070565
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
070574
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
070595
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
070612
METHYLDOPA AND HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
070613
METHYLDOPA AND HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
070614
METHYLDOPA AND HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
070616
METHYLDOPA AND HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
070620
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
070621
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
070654
METHYLDOPA AND CHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
070675
LORAZEPAM
Abbreviated New Drug Application
Approval
070676
LORAZEPAM
Abbreviated New Drug Application
Approval
070677
LORAZEPAM
Abbreviated New Drug Application
Approval
070783
METHYLDOPA AND CHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
070986
IBUPROFEN
Abbreviated New Drug Application
Approval
071142
CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE
Abbreviated New Drug Application
Approval
071178
CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE
Abbreviated New Drug Application
Approval
071179
CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE
Abbreviated New Drug Application
Approval
071288
PROPRANOLOL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
071328
HALOPERIDOL
Abbreviated New Drug Application
Approval
071422
DOXEPIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
071437
DOXEPIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
071575
IBUPROFEN
Abbreviated New Drug Application
Approval
071595
DOXEPIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
071598
LEUCOVORIN CALCIUM
Abbreviated New Drug Application
Approval
071600
LEUCOVORIN CALCIUM
Abbreviated New Drug Application
Approval
071608
DOXEPIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
071669
DOXEPIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
071697
DOXEPIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
071826
MINOXIDIL
Abbreviated New Drug Application
Approval
071839
MINOXIDIL
Abbreviated New Drug Application
Approval
072024
METAPROTERENOL SULFATE
Abbreviated New Drug Application
Approval
072025
METAPROTERENOL SULFATE
Abbreviated New Drug Application
Approval
072077
MECLOFENAMATE SODIUM
Abbreviated New Drug Application
Approval
072078
MECLOFENAMATE SODIUM
Abbreviated New Drug Application
Approval
072277
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
072278
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
072422
MEGESTROL ACETATE
Abbreviated New Drug Application
Approval
072423
MEGESTROL ACETATE
Abbreviated New Drug Application
Approval
072429
FENOPROFEN CALCIUM
Abbreviated New Drug Application
Approval
072437
FENOPROFEN CALCIUM
Abbreviated New Drug Application
Approval
072438
FENOPROFEN CALCIUM
Abbreviated New Drug Application
Approval
074493
CAPTOPRIL
Abbreviated New Drug Application
Approval
074826
ESTAZOLAM
Abbreviated New Drug Application
Approval
074984
DILTIAZEM HYDROCHLORIDE
Abbreviated New Drug Application
Approval
075072
VERAPAMIL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
075162
CLOZAPINE
Abbreviated New Drug Application
Approval
075180
RANITIDINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
075298
FLUTAMIDE
Abbreviated New Drug Application
Approval
075340
HYDROXYUREA
Abbreviated New Drug Application
Approval
075528
CLOMIPHENE CITRATE
Abbreviated New Drug Application
Approval
075671
MEGESTROL ACETATE
Abbreviated New Drug Application
Approval
076009
NABUMETONE
Abbreviated New Drug Application
Approval
076061
PERGOLIDE MESYLATE
Abbreviated New Drug Application
Approval
076159
GLIPIZIDE
Abbreviated New Drug Application
Approval
076218
LATANOPROST
Abbreviated New Drug Application
Tentative Approval
076226
TORSEMIDE
Abbreviated New Drug Application
Approval
076310
CABERGOLINE
Abbreviated New Drug Application
Approval
076475
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Abbreviated New Drug Application
Approval
076506
ONDANSETRON
Abbreviated New Drug Application
Approval
076522
METRONIDAZOLE
Abbreviated New Drug Application
Approval
076744
TESTOSTERONE
Abbreviated New Drug Application
Approval
076893
DONEPEZIL HYDROCHLORIDE
Abbreviated New Drug Application
Tentative Approval
076922
FLUOXETINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
076979
CALCITONIN-SALMON
Abbreviated New Drug Application
Approval
077171
CLONAZEPAM
Abbreviated New Drug Application
Approval
077203
CHOLESTYRAMINE LIGHT
Abbreviated New Drug Application
Approval
077204
CHOLESTYRAMINE
Abbreviated New Drug Application
Approval
077303
ONDANSETRON HYDROCHLORIDE
Abbreviated New Drug Application
Approval
077312
FENTANYL CITRATE
Abbreviated New Drug Application
Approval
077332
SUMATRIPTAN SUCCINATE
Abbreviated New Drug Application
Approval
077406
ONDANSETRON
Abbreviated New Drug Application
Approval
077463
NATEGLINIDE
Abbreviated New Drug Application
Approval
077494
RISPERIDONE
Abbreviated New Drug Application
Approval
077742
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
077827
OXANDROLONE
Abbreviated New Drug Application
Approval
077899
NIFEDIPINE
Abbreviated New Drug Application
Approval
078088
ALPRAZOLAM
Abbreviated New Drug Application
Approval
078109
OLANZAPINE
Abbreviated New Drug Application
Approval
078381
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
078540
PROPAFENONE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
078872
FLUVASTATIN SODIUM
Abbreviated New Drug Application
Tentative Approval
078966
OMEPRAZOLE AND SODIUM BICARBONATE
Abbreviated New Drug Application
Approval
079182
OMEPRAZOLE AND SODIUM BICARBONATE
Abbreviated New Drug Application
Approval
079214
POLYETHYLENE GLYCOL 3350
Abbreviated New Drug Application
Approval
080269
PROPOXYPHENE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
086923
ISOSORBIDE DINITRATE
Abbreviated New Drug Application
Approval
086925
ISOSORBIDE DINITRATE
Abbreviated New Drug Application
Approval
086961
HYDRALAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
086962
HYDRALAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
087005
TRICHLORMETHIAZIDE
Abbreviated New Drug Application
Approval
087007
TRICHLORMETHIAZIDE
Abbreviated New Drug Application
Approval
087009
BROMPHENIRAMINE MALEATE
Abbreviated New Drug Application
Approval
087127
MECLIZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
087128
MECLIZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
087129
CYPROHEPTADINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
087537
ISOSORBIDE DINITRATE
Abbreviated New Drug Application
Approval
087656
HYDROXYZINE PAMOATE
Abbreviated New Drug Application
Approval
087657
HYDROXYZINE PAMOATE
Abbreviated New Drug Application
Approval
087658
HYDROXYZINE PAMOATE
Abbreviated New Drug Application
Approval
087836
HYDRALAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
087946
ISOSORBIDE DINITRATE
Abbreviated New Drug Application
Approval
087981
CHLORZOXAZONE
Abbreviated New Drug Application
Approval
088148
DEXAMETHASONE
Abbreviated New Drug Application
Approval
088149
DEXAMETHASONE
Abbreviated New Drug Application
Approval
088160
DEXAMETHASONE
Abbreviated New Drug Application
Approval
088175
CHLORPROPAMIDE
Abbreviated New Drug Application
Approval
088176
CHLORPROPAMIDE
Abbreviated New Drug Application
Approval
088237
DEXAMETHASONE
Abbreviated New Drug Application
Approval
088238
DEXAMETHASONE
Abbreviated New Drug Application
Approval
088262
IMIPRAMINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088276
IMIPRAMINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088292
IMIPRAMINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088322
THIORIDAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088336
THIORIDAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088351
THIORIDAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088352
THIORIDAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088377
PROPANTHELINE BROMIDE
Abbreviated New Drug Application
Approval
088391
HYDRALAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088480
THIORIDAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088481
DEXAMETHASONE
Abbreviated New Drug Application
Approval
088697
AMITRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088698
AMITRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088699
AMITRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088700
AMITRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088701
AMITRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088702
AMITRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088792
DISULFIRAM
Abbreviated New Drug Application
Approval
088793
DISULFIRAM
Abbreviated New Drug Application
Approval
088850
HYDROFLUMETHIAZIDE
Abbreviated New Drug Application
Approval
088907
RESERPINE AND HYDROFLUMETHIAZIDE
Abbreviated New Drug Application
Approval
088933
SULFINPYRAZONE
Abbreviated New Drug Application
Approval
088934
SULFINPYRAZONE
Abbreviated New Drug Application
Approval
088946
HYDRA-ZIDE
Abbreviated New Drug Application
Approval
088957
HYDRA-ZIDE
Abbreviated New Drug Application
Approval
088961
HYDRA-ZIDE
Abbreviated New Drug Application
Approval
089126
MEPROBAMATE AND ASPIRIN
Abbreviated New Drug Application
Approval
089135
METHYCLOTHIAZIDE
Abbreviated New Drug Application
Approval
089136
METHYCLOTHIAZIDE
Abbreviated New Drug Application
Approval
089145
HYDROXYZINE PAMOATE
Abbreviated New Drug Application
Approval
089146
HYDROXYZINE PAMOATE
Abbreviated New Drug Application
Approval
089207
METHYLPREDNISOLONE
Abbreviated New Drug Application
Approval
089208
METHYLPREDNISOLONE
Abbreviated New Drug Application
Approval
089209
METHYLPREDNISOLONE
Abbreviated New Drug Application
Approval
089422
IMIPRAMINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
089497
IMIPRAMINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
089657
METHOCARBAMOL AND ASPIRIN
Abbreviated New Drug Application
Approval
089674
MECLIZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
089764
THIORIDAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
089765
THIORIDAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
090753
SUMATRIPTAN; NAPROXEN SODIUM
Abbreviated New Drug Application
Tentative Approval
091291
LEVETIRACETAM
Abbreviated New Drug Application
Approval
091340
TRAVOPROST
Abbreviated New Drug Application
Approval
091341
TRAVOPROST
Abbreviated New Drug Application
Tentative Approval
200792
OXYMORPHONE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
201087
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
201791
LAMOTRIGINE
Abbreviated New Drug Application
Approval
201946
OMEPRAZOLE AND SODIUM BICARBONATE
Abbreviated New Drug Application
Approval
202510
DOXEPIN HYDROCHLORIDE
Abbreviated New Drug Application
Tentative Approval
202540
URSODIOL
Abbreviated New Drug Application
Approval
202542
DONEPEZIL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
203918
SODIUM PHENYLBUTYRATE
Abbreviated New Drug Application
Approval
204158
LAMOTRIGINE
Abbreviated New Drug Application
Approval
204395
SODIUM PHENYLBUTYRATE
Abbreviated New Drug Application
Approval
204521
PIMOZIDE
Abbreviated New Drug Application
Approval
205001
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Abbreviated New Drug Application
Approval
Back to Companies who have applied for FDA Drug Approval