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Back to Companies who have applied for FDA Drug Approval
FDA Drug Approval Applications Sponsored by IMPAX LABS
Application Number
Drugs/Products
Application Type
Most Recent Label Available Flag
Current Patent Flag
Action Type
Chemical Type
Ther Potential
Orphan Code
009273
RAUWOLFIA SERPENTINA
New Drug Application
Approval
New manufacturer
(S) Standard review drug
009458
CORTISONE ACETATE
New Drug Application
Approval
New manufacturer
(S) Standard review drug
009627
RESERPINE
New Drug Application
Approval
New manufacturer
(S) Standard review drug
014322
MEPROBAMATE
New Drug Application
Approval
New manufacturer
(S) Standard review drug
040431
FLUDROCORTISONE ACETATE
Abbreviated New Drug Application
Approval
040502
PYRIDOSTIGMINE BROMIDE
Abbreviated New Drug Application
Approval
040516
CHLOROQUINE PHOSPHATE
Abbreviated New Drug Application
Approval
040717
PRIMIDONE
Abbreviated New Drug Application
Approval
040721
BETHANECHOL CHLORIDE
Abbreviated New Drug Application
Approval
040724
PROMETHAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
040739
BETHANECHOL CHLORIDE
Abbreviated New Drug Application
Approval
040740
BETHANECHOL CHLORIDE
Abbreviated New Drug Application
Approval
040741
BETHANECHOL CHLORIDE
Abbreviated New Drug Application
Approval
040782
DIPYRIDAMOLE
Abbreviated New Drug Application
Approval
040791
PROMETHAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
040845
BENZPHETAMINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
060469
TETRACYCLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
060760
OXYTETRACYCLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
065005
MINOCYCLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
065094
DEMECLOCYCLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
075093
PENTOXIFYLLINE
Abbreviated New Drug Application
Approval
075785
OMEPRAZOLE
Abbreviated New Drug Application
Approval
075868
FENOFIBRATE (MICRONIZED)
Abbreviated New Drug Application
Approval
075877
TERBUTALINE SULFATE
Abbreviated New Drug Application
Approval
075913
BUPROPION HYDROCHLORIDE
Abbreviated New Drug Application
Approval
075914
BUPROPION HYDROCHLORIDE
Abbreviated New Drug Application
Approval
075989
LORATADINE AND PSEUDOEPHEDRINE SULFATE
Abbreviated New Drug Application
Approval
076011
LORATADINE
Abbreviated New Drug Application
Approval
076050
LORATADINE AND PSEUDOEPHEDRINE SULFATE
Abbreviated New Drug Application
Approval
076132
RIMANTADINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
076173
RILUZOLE
Abbreviated New Drug Application
Approval
076249
METFORMIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
076318
OXYCODONE HYDROCHLORIDE
Abbreviated New Drug Application
Tentative Approval
076509
FENOFIBRATE
Abbreviated New Drug Application
Approval
076521
CARBIDOPA AND LEVODOPA
Abbreviated New Drug Application
Approval
076711
BUPROPION HYDROCHLORIDE
Abbreviated New Drug Application
Approval
076852
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Abbreviated New Drug Application
Approval
076856
DANTROLENE SODIUM
Abbreviated New Drug Application
Approval
076910
ANAGRELIDE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
076985
METFORMIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
077248
PILOCARPINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
077277
COLESTIPOL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
077415
BUPROPION HYDROCHLORIDE
Abbreviated New Drug Application
Approval
077510
COLESTIPOL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
077833
NADOLOL AND BENDROFLUMETHIAZIDE
Abbreviated New Drug Application
Approval
077968
ALPRAZOLAM
Abbreviated New Drug Application
Approval
077971
BACLOFEN
Abbreviated New Drug Application
Approval
078057
VENLAFAXINE HYDROCHLORIDE
Abbreviated New Drug Application
Tentative Approval
078099
CLONIDINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
078146
BACLOFEN
Abbreviated New Drug Application
Approval
078441
ACARBOSE
Abbreviated New Drug Application
Approval
078484
GALANTAMINE HYDROBROMIDE
Abbreviated New Drug Application
Approval
078556
DIGOXIN
Abbreviated New Drug Application
Approval
078791
DIVALPROEX SODIUM
Abbreviated New Drug Application
Approval
079087
OXYMORPHONE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
080079
SULFA-TRIPLE #2
Abbreviated New Drug Application
Approval
080081
SULFADIAZINE
Abbreviated New Drug Application
Approval
080109
SULFISOXAZOLE
Abbreviated New Drug Application
Approval
080151
THYROGLOBULIN
Abbreviated New Drug Application
Approval
080153
ISONIAZID
Abbreviated New Drug Application
Approval
080159
PROPYLTHIOURACIL
Abbreviated New Drug Application
Approval
080686
FOLIC ACID
Abbreviated New Drug Application
Approval
080767
METHYLTESTOSTERONE
Abbreviated New Drug Application
Approval
080780
PREDNISOLONE
Abbreviated New Drug Application
Approval
080781
HYDROCORTISONE
Abbreviated New Drug Application
Approval
080782
PREDNISONE
Abbreviated New Drug Application
Approval
080785
TRIPELENNAMINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
080807
DIPHENHYDRAMINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
080808
PYRILAMINE MALEATE
Abbreviated New Drug Application
Approval
080809
CHLORPHENIRAMINE MALEATE
Abbreviated New Drug Application
Approval
080874
PIPERAZINE CITRATE
Abbreviated New Drug Application
Approval
080880
CHLOROQUINE PHOSPHATE
Abbreviated New Drug Application
Approval
080951
VITAMIN D
Abbreviated New Drug Application
Approval
080952
VITAMIN A
Abbreviated New Drug Application
Approval
080953
VITAMIN A
Abbreviated New Drug Application
Approval
080955
VITAMIN A
Abbreviated New Drug Application
Approval
083115
NIACIN
Abbreviated New Drug Application
Approval
083317
PROPOXYPHENE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
083347
QUINIDINE SULFATE
Abbreviated New Drug Application
Approval
083607
HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
083720
PROBENECID AND COLCHICINE
Abbreviated New Drug Application
Approval
083967
TRICHLORMETHIAZIDE
Abbreviated New Drug Application
Approval
084029
HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
084214
PROMETHAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
084287
METHYLTESTOSTERONE
Abbreviated New Drug Application
Approval
084310
METHYLTESTOSTERONE
Abbreviated New Drug Application
Approval
084340
TRIAMCINOLONE
Abbreviated New Drug Application
Approval
084541
PROPANTHELINE BROMIDE
Abbreviated New Drug Application
Approval
084574
AMINOPHYLLINE
Abbreviated New Drug Application
Approval
084575
AMINOPHYLLINE
Abbreviated New Drug Application
Approval
084576
AMINOPHYLLINE
Abbreviated New Drug Application
Approval
084577
AMINOPHYLLINE
Abbreviated New Drug Application
Approval
084922
HYDRALAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
084923
HYDRALAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
084927
METHOCARBAMOL
Abbreviated New Drug Application
Approval
084928
METHOCARBAMOL
Abbreviated New Drug Application
Approval
085098
HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
085113
CHLORDIAZEPOXIDE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
085376
DEXAMETHASONE
Abbreviated New Drug Application
Approval
086212
CHLORDIAZEPOXIDE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
086213
CHLORDIAZEPOXIDE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
090377
TAMSULOSIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
090631
CARBIDOPA AND LEVODOPA
Abbreviated New Drug Application
Approval
091638
LETROZOLE
Abbreviated New Drug Application
Approval
Back to Companies who have applied for FDA Drug Approval