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Back to Companies who have applied for FDA Drug Approval
FDA Drug Approval Applications Sponsored by TEVA PHARMS USA
Application Number
Drugs/Products
Application Type
Most Recent Label Available Flag
Current Patent Flag
Action Type
Chemical Type
Ther Potential
Orphan Code
020622
COPAXONE
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
(V) Orphan drug
022453
TOPOTECAN HYDROCHLORIDE
New Drug Application
Approval
New manufacturer
(S) Standard review drug
040174
LEUCOVORIN CALCIUM
Abbreviated New Drug Application
Approval
040333
FLUOROURACIL
Abbreviated New Drug Application
Approval
040334
FLUOROURACIL
Abbreviated New Drug Application
Approval
040454
PROMETHAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
040455
NOREPINEPHRINE BITARTRATE
Abbreviated New Drug Application
Approval
040557
METHYLPREDNISOLONE ACETATE
Abbreviated New Drug Application
Approval
040620
METHYLPREDNISOLONE ACETATE
Abbreviated New Drug Application
Approval
050577
ZANOSAR
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
063100
TOBRAMYCIN SULFATE
Abbreviated New Drug Application
Approval
064045
AMIKACIN SULFATE
Abbreviated New Drug Application
Approval
064140
DOXORUBICIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
065033
BLEOMYCIN SULFATE
Abbreviated New Drug Application
Approval
065035
DAUNORUBICIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
065036
IDARUBICIN HYDROCHLORIDE PFS
Abbreviated New Drug Application
Approval
065096
AMOXICILLIN AND CLAVULANATE POTASSIUM
Abbreviated New Drug Application
Approval
065227
CEFTRIAXONE
Abbreviated New Drug Application
Approval
070027
METRONIDAZOLE
Abbreviated New Drug Application
Approval
071523
TRAZODONE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
071524
TRAZODONE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
071655
OXYBUTYNIN CHLORIDE
Abbreviated New Drug Application
Approval
072759
PANCURONIUM BROMIDE
Abbreviated New Drug Application
Approval
072760
PANCURONIUM BROMIDE
Abbreviated New Drug Application
Approval
073135
METOCLOPRAMIDE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
073303
SULFAMETHOXAZOLE AND TRIMETHOPRIM
Abbreviated New Drug Application
Approval
074087
CLOBETASOL PROPIONATE
Abbreviated New Drug Application
Approval
074284
ETOPOSIDE
Abbreviated New Drug Application
Approval
074529
ETOPOSIDE
Abbreviated New Drug Application
Approval
074688
VECURONIUM BROMIDE
Abbreviated New Drug Application
Approval
074814
CISPLATIN
Abbreviated New Drug Application
Approval
074888
DESMOPRESSIN ACETATE
Abbreviated New Drug Application
Approval
074894
DILTIAZEM HYDROCHLORIDE
Abbreviated New Drug Application
Approval
074952
DIPYRIDAMOLE
Abbreviated New Drug Application
Approval
075196
ALPROSTADIL
Abbreviated New Drug Application
Approval
075206
CYTOSAR-U
Abbreviated New Drug Application
Approval
075259
DACARBAZINE
Abbreviated New Drug Application
Approval
075297
PACLITAXEL
Abbreviated New Drug Application
Approval
075313
IPRATROPIUM BROMIDE
Abbreviated New Drug Application
Approval
075393
HALOPERIDOL DECANOATE
Abbreviated New Drug Application
Approval
075471
LEUPROLIDE ACETATE
Abbreviated New Drug Application
Approval
075493
VINCRISTINE SULFATE PFS
Abbreviated New Drug Application
Approval
075578
ENALAPRILAT
Abbreviated New Drug Application
Approval
075764
MESNA
Abbreviated New Drug Application
Approval
075874
IFOSFAMIDE/MESNA KIT
Abbreviated New Drug Application
Approval
075881
LEVOCARNITINE
Abbreviated New Drug Application
Approval
075957
OCTREOTIDE ACETATE
Abbreviated New Drug Application
Approval
075959
OCTREOTIDE ACETATE
Abbreviated New Drug Application
Approval
076001
FLUOXETINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
076028
VINORELBINE TARTRATE
Abbreviated New Drug Application
Approval
076035
HALOPERIDOL
Abbreviated New Drug Application
Approval
076135
CLARAVIS
Abbreviated New Drug Application
Approval
076153
PAMIDRONATE DISODIUM
Abbreviated New Drug Application
Approval
076163
AMIODARONE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
076356
CLARAVIS
Abbreviated New Drug Application
Approval
076552
MEDROXYPROGESTERONE ACETATE
Abbreviated New Drug Application
Approval
076553
MEDROXYPROGESTERONE ACETATE
Abbreviated New Drug Application
Approval
076564
ADENOSINE
Abbreviated New Drug Application
Approval
076589
FLUMAZENIL
Abbreviated New Drug Application
Approval
076653
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
Abbreviated New Drug Application
Approval
076657
IFOSFAMIDE
Abbreviated New Drug Application
Approval
076765
ESCITALOPRAM OXALATE
Abbreviated New Drug Application
Approval
076822
RABEPRAZOLE SODIUM
Abbreviated New Drug Application
Approval
076853
TERBUTALINE SULFATE
Abbreviated New Drug Application
Approval
076886
FOSPHENYTOIN SODIUM
Abbreviated New Drug Application
Approval
077132
RISEDRONATE SODIUM
Abbreviated New Drug Application
Approval
077139
CARBOPLATIN
Abbreviated New Drug Application
Approval
077165
GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE
Abbreviated New Drug Application
Approval
077210
PIOGLITAZONE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
077297
GRANISETRON HYDROCHLORIDE
Abbreviated New Drug Application
Approval
077356
MITOXANTRONE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
077425
ADENOSINE
Abbreviated New Drug Application
Approval
077437
MOXIFLOXACIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
077453
OXYTOCIN
Abbreviated New Drug Application
Approval
077782
CIPROFLOXACIN
Abbreviated New Drug Application
Approval
077907
SUMATRIPTAN SUCCINATE
Abbreviated New Drug Application
Approval
077963
GRANISETRON HYDROCHLORIDE
Abbreviated New Drug Application
Approval
078027
ALMOTRIPTAN MALATE
Abbreviated New Drug Application
Approval
078061
LINEZOLID
Abbreviated New Drug Application
Approval
078193
RALOXIFENE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
078392
GRANISETRON HYDROCHLORIDE
Abbreviated New Drug Application
Approval
078396
EPOPROSTENOL SODIUM
Abbreviated New Drug Application
Approval
078607
ARIPIPRAZOLE
Abbreviated New Drug Application
Approval
078608
ARIPIPRAZOLE
Abbreviated New Drug Application
Approval
078676
ADENOSINE
Abbreviated New Drug Application
Approval
078708
ARIPIPRAZOLE
Abbreviated New Drug Application
Approval
078709
ROSIGLITAZONE MALEATE AND GLIMEPIRIDE
Abbreviated New Drug Application
Approval
078746
CARBAMAZEPINE
Abbreviated New Drug Application
Tentative Approval
078908
DEXMETHYLPHENIDATE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
079011
FLUVASTATIN SODIUM
Abbreviated New Drug Application
Approval
079166
ROSUVASTATIN CALCIUM
Abbreviated New Drug Application
Approval
079184
URSODIOL
Abbreviated New Drug Application
Approval
079215
RISEDRONATE SODIUM
Abbreviated New Drug Application
Approval
079246
ABACAVIR SULFATE AND LAMIVUDINE
Abbreviated New Drug Application
Approval
081277
LEUCOVORIN CALCIUM
Abbreviated New Drug Application
Approval
087353
CHLORPROPAMIDE
Abbreviated New Drug Application
Approval
088641
GLUCAMIDE
Abbreviated New Drug Application
Approval
089457
PERPHENAZINE
Abbreviated New Drug Application
Approval
089707
PERPHENAZINE
Abbreviated New Drug Application
Approval
089708
PERPHENAZINE
Abbreviated New Drug Application
Approval
090101
IRINOTECAN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
090297
LEVALBUTEROL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
090352
PEMETREXED
Abbreviated New Drug Application
Tentative Approval
090713
PALONOSETRON HYDROCHLORIDE
Abbreviated New Drug Application
Tentative Approval
090783
DULOXETINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
090829
PARICALCITOL
Abbreviated New Drug Application
Approval
090854
EPTIFIBATIDE
Abbreviated New Drug Application
Approval
090861
ZOLMITRIPTAN
Abbreviated New Drug Application
Approval
091028
OMEGA-3-ACID ETHYL ESTERS
Abbreviated New Drug Application
Approval
091059
ERLOTINIB HYDROCHLORIDE
Abbreviated New Drug Application
Approval
091079
OLMESARTAN MEDOXOMIL
Abbreviated New Drug Application
Tentative Approval
091141
FORMOTEROL FUMARATE
Abbreviated New Drug Application
Tentative Approval
091149
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
091154
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Abbreviated New Drug Application
Approval
091155
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
091175
EFAVIRENZ
Abbreviated New Drug Application
Tentative Approval
091235
AMLODIPINE BESYLATE AND VALSARTAN
Abbreviated New Drug Application
Approval
091464
SOLIFENACIN SUCCINATE
Abbreviated New Drug Application
Approval
091555
EPTIFIBATIDE
Abbreviated New Drug Application
Approval
091583
PARICALCITOL
Abbreviated New Drug Application
Tentative Approval
091589
TOBRAMYCIN
Abbreviated New Drug Application
Approval
091612
TENOFOVIR DISOPROXIL FUMARATE
Abbreviated New Drug Application
Approval
091649
CAPECITABINE
Abbreviated New Drug Application
Approval
091673
ATAZANAVIR SULFATE
Abbreviated New Drug Application
Approval
200151
SELFEMRA
Abbreviated New Drug Application
Approval
200218
LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN
Abbreviated New Drug Application
Approval
200293
ARFORMOTEROL TARTRATE
Abbreviated New Drug Application
Tentative Approval
200747
ESTRADIOL AND NORETHINDRONE ACETATE
Abbreviated New Drug Application
Approval
200887
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Tentative Approval
201250
VANCOMYCIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
201251
VANCOMYCIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
201382
GUANFACINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
201920
VARENICLINE
Abbreviated New Drug Application
Tentative Approval
202040
ELETRIPTAN HYDROBROMIDE
Abbreviated New Drug Application
Tentative Approval
202118
DARUNAVIR ETHANOLATE
Abbreviated New Drug Application
Tentative Approval
202122
ENTECAVIR
Abbreviated New Drug Application
Approval
202487
SITAGLIPTIN PHOSPHATE
Abbreviated New Drug Application
Tentative Approval
202491
OLMESARTAN MEDOXOMIL; AMLODIPINE; HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
202718
MORPHINE SULFATE
Abbreviated New Drug Application
Approval
202720
MYCOPHENOLIC ACID
Abbreviated New Drug Application
Approval
202731
DEXMETHYLPHENIDATE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
202897
ACITRETIN
Abbreviated New Drug Application
Approval
202999
ESTRADIOL VALERATE; ESTRADIOL VALERATE; DIENOGEST
Abbreviated New Drug Application
Tentative Approval
203039
CLOZAPINE
Abbreviated New Drug Application
Approval
203217
RISEDRONATE SODIUM
Abbreviated New Drug Application
Approval
203877
DOCETAXEL
Abbreviated New Drug Application
Approval
204285
IMATINIB MESYLATE
Abbreviated New Drug Application
Approval
204548
BUDESONIDE
Abbreviated New Drug Application
Approval
205208
DESVENLAFAXINE
New Drug Application
Approval
New manufacturer
(S) Standard review drug
206769
ARGATROBAN IN 0.9% SODIUM CHLORIDE
New Drug Application
Approval
New manufacturer
(S) Standard review drug
208212
VILAZODONE HYDROCHLORIDE
Abbreviated New Drug Application
Tentative Approval
Back to Companies who have applied for FDA Drug Approval