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Back to Companies who have applied for FDA Drug Approval
FDA Drug Approval Applications Sponsored by TEVA PHARMS
Application Number
Drugs/Products
Application Type
Most Recent Label Available Flag
Current Patent Flag
Action Type
Chemical Type
Ther Potential
Orphan Code
021806
VANDAZOLE
New Drug Application
Approval
New manufacturer
(S) Standard review drug
022160
OXALIPLATIN
New Drug Application
Approval
New manufacturer
(S) Standard review drug
040081
HYDROXYCHLOROQUINE SULFATE
Abbreviated New Drug Application
Approval
040120
PROCHLORPERAZINE MALEATE
Abbreviated New Drug Application
Approval
040322
PREDNISOLONE
Abbreviated New Drug Application
Approval
040472
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Abbreviated New Drug Application
Approval
062774
CEFADROXIL
Abbreviated New Drug Application
Approval
063016
CEFAZOLIN SODIUM
Abbreviated New Drug Application
Approval
063018
CEFAZOLIN SODIUM
Abbreviated New Drug Application
Approval
064191
CEFUROXIME SODIUM
Abbreviated New Drug Application
Approval
064192
CEFUROXIME SODIUM
Abbreviated New Drug Application
Approval
065236
CEFPROZIL
Abbreviated New Drug Application
Approval
065282
CEFADROXIL
Abbreviated New Drug Application
Approval
065332
CEFDINIR
Abbreviated New Drug Application
Approval
065368
CEFDINIR
Abbreviated New Drug Application
Approval
065419
AZITHROMYCIN
Abbreviated New Drug Application
Approval
065457
MYCOPHENOLATE MOFETIL
Abbreviated New Drug Application
Approval
065491
MYCOPHENOLATE MOFETIL
Abbreviated New Drug Application
Approval
070030
SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH
Abbreviated New Drug Application
Approval
070153
DIAZEPAM
Abbreviated New Drug Application
Approval
071554
THIOTHIXENE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
071609
DOXEPIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
071617
HALOPERIDOL
Abbreviated New Drug Application
Approval
071745
PRAZOSIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
071883
BETAMETHASONE VALERATE
Abbreviated New Drug Application
Approval
072522
FLUOCINONIDE
Abbreviated New Drug Application
Approval
073058
FLUPHENAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
073095
CLEMASTINE FUMARATE
Abbreviated New Drug Application
Approval
073115
AMANTADINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
073249
GYNIX
Abbreviated New Drug Application
Approval
073497
EVALOSE
Abbreviated New Drug Application
Approval
073504
HEPTALAC
Abbreviated New Drug Application
Approval
074030
MICONAZOLE NITRATE
Abbreviated New Drug Application
Approval
074067
DILTIAZEM HYDROCHLORIDE
Abbreviated New Drug Application
Approval
074103
PIROXICAM
Abbreviated New Drug Application
Approval
074120
ATENOLOL
Abbreviated New Drug Application
Approval
074171
HYDROCORTISONE
Abbreviated New Drug Application
Approval
074207
NAPROXEN
Abbreviated New Drug Application
Approval
074289
NAPROXEN SODIUM
Abbreviated New Drug Application
Approval
074333
METOPROLOL TARTRATE
Abbreviated New Drug Application
Approval
074368
NADOLOL
Abbreviated New Drug Application
Approval
074459
DICLOFENAC SODIUM
Abbreviated New Drug Application
Approval
074555
CHOLESTYRAMINE LIGHT
Abbreviated New Drug Application
Approval
074739
AMIODARONE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
074873
TRETINOIN
Abbreviated New Drug Application
Approval
074914
ACYCLOVIR
Abbreviated New Drug Application
Approval
075021
ACYCLOVIR
Abbreviated New Drug Application
Approval
075030
PEMOLINE
Abbreviated New Drug Application
Approval
075184
PACLITAXEL
Abbreviated New Drug Application
Approval
075271
CROMOLYN SODIUM
Abbreviated New Drug Application
Approval
075343
ALBUTEROL SULFATE
Abbreviated New Drug Application
Approval
075435
GABAPENTIN
Abbreviated New Drug Application
Approval
075555
PEMOLINE
Abbreviated New Drug Application
Approval
075592
URSODIOL
Abbreviated New Drug Application
Approval
075644
BISOPROLOL FUMARATE
Abbreviated New Drug Application
Approval
075681
MEGESTROL ACETATE
Abbreviated New Drug Application
Approval
076000
OLANZAPINE
Abbreviated New Drug Application
Approval
076184
ALENDRONATE SODIUM
Abbreviated New Drug Application
Approval
076532
SIMVASTATIN
Abbreviated New Drug Application
Tentative Approval
076596
MODAFINIL
Abbreviated New Drug Application
Tentative Approval
076724
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
Abbreviated New Drug Application
Approval
076837
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Abbreviated New Drug Application
Approval
077082
PAROXETINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
077084
LEFLUNOMIDE
Abbreviated New Drug Application
Approval
077107
DEXMETHYLPHENIDATE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
077138
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Abbreviated New Drug Application
Approval
077157
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
077159
IRBESARTAN
Abbreviated New Drug Application
Approval
077179
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
077213
CITALOPRAM HYDROBROMIDE
Abbreviated New Drug Application
Approval
077239
ZALEPLON
Abbreviated New Drug Application
Approval
077255
LANSOPRAZOLE
Abbreviated New Drug Application
Approval
077263
RIZATRIPTAN BENZOATE
Abbreviated New Drug Application
Approval
077270
GLIPIZIDE AND METFORMIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
077279
CETIRIZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
077412
ESCITALOPRAM OXALATE
Abbreviated New Drug Application
Tentative Approval
077445
POLYETHYLENE GLYCOL 3350
Abbreviated New Drug Application
Approval
077467
NATEGLINIDE
Abbreviated New Drug Application
Approval
077470
RAMIPRIL
Abbreviated New Drug Application
Approval
077487
FAMCICLOVIR
Abbreviated New Drug Application
Approval
077489
TRANDOLAPRIL
Abbreviated New Drug Application
Approval
077519
BUDESONIDE
Abbreviated New Drug Application
Approval
077528
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
077587
GALANTAMINE HYDROBROMIDE
Abbreviated New Drug Application
Approval
077611
RIBAVIRIN
Abbreviated New Drug Application
Tentative Approval
077630
TAMSULOSIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
077655
VALACYCLOVIR HYDROCHLORIDE
Abbreviated New Drug Application
Approval
077707
METHYLPHENIDATE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
077745
QUETIAPINE FUMARATE
Abbreviated New Drug Application
Approval
077793
PRAVASTATIN SODIUM
Abbreviated New Drug Application
Approval
077936
MELOXICAM
Abbreviated New Drug Application
Approval
077983
GEMCITABINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
078058
ANASTROZOLE
Abbreviated New Drug Application
Approval
078073
MOXIFLOXACIN HYDROCHLORIDE
Abbreviated New Drug Application
Tentative Approval
078079
CICLOPIROX
Abbreviated New Drug Application
Approval
078080
GRANISETRON HYDROCHLORIDE
Abbreviated New Drug Application
Approval
078101
LEVETIRACETAM
Abbreviated New Drug Application
Approval
078104
TRIAMCINOLONE ACETONIDE
Abbreviated New Drug Application
Approval
078380
SILDENAFIL CITRATE
Abbreviated New Drug Application
Approval
078407
FLUVASTATIN SODIUM
Abbreviated New Drug Application
Approval
078592
CARBAMAZEPINE
Abbreviated New Drug Application
Approval
078605
MONTELUKAST SODIUM
Abbreviated New Drug Application
Approval
078636
LAMIVUDINE
Abbreviated New Drug Application
Tentative Approval
078704
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
Abbreviated New Drug Application
Approval
078717
ROCURONIUM BROMIDE
Abbreviated New Drug Application
Approval
078723
MONTELUKAST SODIUM
Abbreviated New Drug Application
Approval
078729
ARSENIC TRIOXIDE
Abbreviated New Drug Application
Tentative Approval
078751
NARATRIPTAN
Abbreviated New Drug Application
Approval
078756
DORZOLAMIDE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
078773
ATORVASTATIN CALCIUM
Abbreviated New Drug Application
Approval
078873
METHYLPHENIDATE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
079056
ALFUZOSIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
079081
LAMIVUDINE AND ZIDOVUDINE
Abbreviated New Drug Application
Approval
081236
THEOPHYLLINE
Abbreviated New Drug Application
Approval
081306
ETHOSUXIMIDE
Abbreviated New Drug Application
Approval
089602
THIORIDAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
090052
MEMANTINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
090199
LEVOCETIRIZINE DIHYDROCHLORIDE
Abbreviated New Drug Application
Approval
090241
PRAMIPEXOLE DIHYDROCHLORIDE
Abbreviated New Drug Application
Approval
090289
LETROZOLE
Abbreviated New Drug Application
Approval
090539
CINACALCET HYDROCHLORIDE
Abbreviated New Drug Application
Tentative Approval
090625
CLOPIDOGREL BISULFATE
Abbreviated New Drug Application
Approval
090894
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Abbreviated New Drug Application
Tentative Approval
090955
MONTELUKAST SODIUM
Abbreviated New Drug Application
Approval
091215
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Abbreviated New Drug Application
Tentative Approval
091219
PREGABALIN
Abbreviated New Drug Application
Tentative Approval
091224
PREGABALIN
Abbreviated New Drug Application
Tentative Approval
091347
VARDENAFIL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
091430
LEVETIRACETAM
Abbreviated New Drug Application
Approval
091658
VORICONAZOLE
Abbreviated New Drug Application
Approval
091661
QUININE SULFATE
Abbreviated New Drug Application
Approval
200222
LINEZOLID
Abbreviated New Drug Application
Approval
200435
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
202074
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
202121
PROGESTERONE
Abbreviated New Drug Application
Approval
208174
RANOLAZINE
Abbreviated New Drug Application
Tentative Approval
Back to Companies who have applied for FDA Drug Approval