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Back to Companies who have applied for FDA Drug Approval
FDA Drug Approval Applications Sponsored by AMNEAL PHARMS
Application Number
Drugs/Products
Application Type
Most Recent Label Available Flag
Current Patent Flag
Action Type
Chemical Type
Ther Potential
Orphan Code
040882
PROMETHAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
040902
PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
076003
TRAMADOL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
078267
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
Abbreviated New Drug Application
Approval
078312
RANITIDINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
078345
PREDNISOLONE SODIUM PHOSPHATE
Abbreviated New Drug Application
Approval
078826
LORAZEPAM
Abbreviated New Drug Application
Approval
078892
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
Abbreviated New Drug Application
Approval
079098
VENLAFAXINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
079233
IBUPROFEN
Abbreviated New Drug Application
Approval
079241
ALBUTEROL SULFATE
Abbreviated New Drug Application
Approval
090041
MEMANTINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
090485
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Abbreviated New Drug Application
Approval
090575
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
Abbreviated New Drug Application
Approval
090576
NIZATIDINE
Abbreviated New Drug Application
Approval
090765
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
Abbreviated New Drug Application
Approval
090766
CETIRIZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
090992
LEVETIRACETAM
Abbreviated New Drug Application
Approval
091383
LORAZEPAM
Abbreviated New Drug Application
Approval
091384
RISPERIDONE
Abbreviated New Drug Application
Approval
091426
SPIRONOLACTONE
Abbreviated New Drug Application
Approval
091483
ONDANSETRON HYDROCHLORIDE
Abbreviated New Drug Application
Approval
091549
INDOMETHACIN
Abbreviated New Drug Application
Approval
200275
NORETHINDRONE ACETATE
Abbreviated New Drug Application
Approval
200457
IBUPROFEN
Abbreviated New Drug Application
Approval
200894
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
Abbreviated New Drug Application
Approval
200963
PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE
Abbreviated New Drug Application
Approval
201095
LEVONORGESTREL AND ETHINYL ESTRADIOL
Abbreviated New Drug Application
Approval
201108
LEVONORGESTREL AND ETHINYL ESTRADIOL
Abbreviated New Drug Application
Approval
201451
MECLIZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
201658
CALCIUM ACETATE
Abbreviated New Drug Application
Approval
201679
NITROFURANTOIN
Abbreviated New Drug Application
Approval
201680
FELBAMATE
Abbreviated New Drug Application
Approval
202023
SILDENAFIL CITRATE
Abbreviated New Drug Application
Tentative Approval
202024
GABAPENTIN
Abbreviated New Drug Application
Approval
202025
SILDENAFIL CITRATE
Abbreviated New Drug Application
Approval
202128
POTASSIUM CHLORIDE
Abbreviated New Drug Application
Approval
202202
WARFARIN SODIUM
Abbreviated New Drug Application
Approval
202227
ESCITALOPRAM OXALATE
Abbreviated New Drug Application
Approval
202260
NORETHINDRONE
Abbreviated New Drug Application
Approval
202300
IBUPROFEN
Abbreviated New Drug Application
Approval
202385
FELBAMATE
Abbreviated New Drug Application
Approval
202830
LISDEXAMFETAMINE DIMESYLATE
Abbreviated New Drug Application
Tentative Approval
202960
ATOVAQUONE
Abbreviated New Drug Application
Approval
202961
OXCARBAZEPINE
Abbreviated New Drug Application
Approval
203118
DUTASTERIDE
Abbreviated New Drug Application
Approval
203136
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
203278
DOXYCYCLINE
Abbreviated New Drug Application
Tentative Approval
203399
METAXALONE
Abbreviated New Drug Application
Approval
203482
TEMAZEPAM
Abbreviated New Drug Application
Approval
203513
CLINDAMYCIN PALMITATE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
203578
NIACIN
Abbreviated New Drug Application
Approval
203638
OXYCODONE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
203691
TEMOZOLOMIDE
Abbreviated New Drug Application
Approval
203729
QUININE SULFATE
Abbreviated New Drug Application
Approval
203730
DIVALPROEX SODIUM
Abbreviated New Drug Application
Approval
203751
CLOPIDOGREL BISULFATE
Abbreviated New Drug Application
Approval
203865
NORGESTIMATE AND ETHINYL ESTRADIOL
Abbreviated New Drug Application
Approval
203870
NORGESTIMATE AND ETHINYL ESTRADIOL
Abbreviated New Drug Application
Approval
203871
LEVONORGESTREL AND ETHINYL ESTRADIOL
Abbreviated New Drug Application
Approval
203906
ARIPIPRAZOLE
Abbreviated New Drug Application
Approval
204010
OXYBUTYNIN CHLORIDE
Abbreviated New Drug Application
Approval
204011
VALSARTAN
Abbreviated New Drug Application
Approval
204178
NIACIN
Abbreviated New Drug Application
Approval
204179
RABEPRAZOLE SODIUM
Abbreviated New Drug Application
Approval
204327
PARICALCITOL
Abbreviated New Drug Application
Approval
204415
TELMISARTAN
Abbreviated New Drug Application
Approval
204536
LINEZOLID
Abbreviated New Drug Application
Approval
204604
MONTELUKAST SODIUM
Abbreviated New Drug Application
Approval
204605
ACYCLOVIR
Abbreviated New Drug Application
Approval
204838
ARIPIPRAZOLE
Abbreviated New Drug Application
Approval
204839
LACOSAMIDE
Abbreviated New Drug Application
Approval
204857
LACOSAMIDE
Abbreviated New Drug Application
Approval
204940
OMEGA-3-ACID ETHYL ESTERS
Abbreviated New Drug Application
Approval
205002
FESOTERODINE FUMARATE
Abbreviated New Drug Application
Tentative Approval
205034
VORICONAZOLE
Abbreviated New Drug Application
Approval
205080
ITRACONAZOLE
Abbreviated New Drug Application
Approval
205081
MILNACIPRAN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
205119
PANTOPRAZOLE SODIUM
Abbreviated New Drug Application
Approval
205256
ESTRADIOL
Abbreviated New Drug Application
Approval
205501
TOBRAMYCIN
Abbreviated New Drug Application
Approval
205573
ITRACONAZOLE
Abbreviated New Drug Application
Approval
205825
MEMANTINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
205883
MEROPENEM
Abbreviated New Drug Application
Approval
205941
SAXAGLIPTIN
Abbreviated New Drug Application
Tentative Approval
205942
SAXAGLIPTIN;METFORMIN HYDROCHLORIDE
Abbreviated New Drug Application
Tentative Approval
206116
DICLOFENAC SODIUM
Abbreviated New Drug Application
Approval
206297
LIDOCAINE
Abbreviated New Drug Application
Approval
206392
ASPIRIN AND DIPYRIDAMOLE
Abbreviated New Drug Application
Approval
206652
ENTECAVIR
Abbreviated New Drug Application
Approval
207289
DOXYCYCLINE HYCLATE
Abbreviated New Drug Application
Approval
207514
NORETHINDRONE ACETATE ETHINYL ESTRADIOL; FERROUS FUMARATE
Abbreviated New Drug Application
Tentative Approval
207547
LEVOLEUCOVORIN
Abbreviated New Drug Application
Tentative Approval
208077
DICLOFENAC SODIUM
Abbreviated New Drug Application
Approval
208198
DICLOFENAC SODIUM
Abbreviated New Drug Application
Tentative Approval
208206
RALOXIFENE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
Back to Companies who have applied for FDA Drug Approval