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Back to Companies who have applied for FDA Drug Approval
FDA Drug Approval Applications Sponsored by TARO
Application Number
Drugs/Products
Application Type
Most Recent Label Available Flag
Current Patent Flag
Action Type
Chemical Type
Ther Potential
Orphan Code
011366
DARANIDE
KEVEYIS
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
019117
FLUOCINONIDE
New Drug Application
Approval
021143
TRIVAGIZOLE 3
New Drug Application
Approval
New formulation
(S) Standard review drug
021734
LORATADINE
New Drug Application
Approval
New formulation
(S) Standard review drug
022067
FLO-PRED
New Drug Application
Approval
New formulation
(S) Standard review drug
040035
FLUOCINOLONE ACETONIDE
Abbreviated New Drug Application
Approval
040037
TRIAMCINOLONE ACETONIDE
Abbreviated New Drug Application
Approval
040038
TRIAMCINOLONE ACETONIDE
Abbreviated New Drug Application
Approval
040039
TRIAMCINOLONE ACETONIDE
Abbreviated New Drug Application
Approval
040040
TRIAMCINOLONE ACETONIDE
Abbreviated New Drug Application
Approval
040041
FLUOCINOLONE ACETONIDE
Abbreviated New Drug Application
Approval
040042
FLUOCINOLONE ACETONIDE
Abbreviated New Drug Application
Approval
040195
ACETAZOLAMIDE
Abbreviated New Drug Application
Approval
040247
HYDROCORTISONE
Abbreviated New Drug Application
Approval
040301
WARFARIN SODIUM
Abbreviated New Drug Application
Approval
040310
HYDROCORTISONE
Abbreviated New Drug Application
Approval
040374
TRIAMCINOLONE ACETONIDE
Abbreviated New Drug Application
Approval
040386
TRIAMCINOLONE ACETONIDE
Abbreviated New Drug Application
Approval
040521
PHENYTOIN
Abbreviated New Drug Application
Approval
040603
PROMETHAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
040684
EXTENDED PHENYTOIN SODIUM
Abbreviated New Drug Application
Approval
040718
PROMETHAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
062347
NYSTATIN AND TRIAMCINOLONE ACETONIDE
Abbreviated New Drug Application
Approval
062364
NYSTATIN AND TRIAMCINOLONE ACETONIDE
Abbreviated New Drug Application
Approval
062427
GENTAMICIN SULFATE
Abbreviated New Drug Application
Approval
062457
NYSTATIN
Abbreviated New Drug Application
Approval
062477
GENTAMICIN SULFATE
Abbreviated New Drug Application
Approval
062876
NYSTATIN
Abbreviated New Drug Application
Approval
063305
NYSTATIN AND TRIAMCINOLONE ACETONIDE
Abbreviated New Drug Application
Approval
064022
NYSTATIN
Abbreviated New Drug Application
Approval
065170
MUPIROCIN
Abbreviated New Drug Application
Approval
070062
BETAMETHASONE VALERATE
Abbreviated New Drug Application
Approval
070730
TRIAMCINOLONE ACETONIDE
Abbreviated New Drug Application
Approval
071143
BETAMETHASONE DIPROPIONATE
Abbreviated New Drug Application
Approval
071383
ORALONE
Abbreviated New Drug Application
Approval
071500
FLUOCINONIDE
Abbreviated New Drug Application
Approval
072041
DERMABET
Abbreviated New Drug Application
Approval
072276
BETAMETHASONE DIPROPIONATE
Abbreviated New Drug Application
Approval
072494
FLUOCINONIDE EMULSIFIED BASE
Abbreviated New Drug Application
Approval
072640
CLOTRIMAZOLE
Abbreviated New Drug Application
Approval
072641
CLOTRIMAZOLE
Abbreviated New Drug Application
Approval
072857
FLUOCINONIDE
Abbreviated New Drug Application
Approval
073193
TOPICORT
Abbreviated New Drug Application
Approval
073210
TOPICORT
Abbreviated New Drug Application
Approval
073548
DESONIDE
Abbreviated New Drug Application
Approval
073552
BETAMETHASONE DIPROPIONATE
Abbreviated New Drug Application
Approval
074248
CLOBETASOL PROPIONATE
Abbreviated New Drug Application
Approval
074249
CLOBETASOL PROPIONATE
Abbreviated New Drug Application
Approval
074254
DESONIDE
Abbreviated New Drug Application
Approval
074271
BETAMETHASONE DIPROPIONATE
Abbreviated New Drug Application
Approval
074272
BETAMETHASONE DIPROPIONATE
Abbreviated New Drug Application
Approval
074286
TOPICORT
Abbreviated New Drug Application
Approval
074444
MICONAZOLE NITRATE
Abbreviated New Drug Application
Approval
074580
CLOTRIMAZOLE
Abbreviated New Drug Application
Approval
074649
CARBAMAZEPINE
Abbreviated New Drug Application
Approval
074694
CLOMIPRAMINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
074799
FLUOCINONIDE
Abbreviated New Drug Application
Approval
074904
TOPICORT
Abbreviated New Drug Application
Approval
074935
FLUOCINONIDE
Abbreviated New Drug Application
Approval
075008
FLUOCINONIDE
Abbreviated New Drug Application
Approval
075042
HYDROCORTISONE VALERATE
Abbreviated New Drug Application
Approval
075043
HYDROCORTISONE VALERATE
Abbreviated New Drug Application
Approval
075078
ETODOLAC
Abbreviated New Drug Application
Approval
075224
CLOBETASOL PROPIONATE
Abbreviated New Drug Application
Approval
075279
CLOBETASOL PROPIONATE
Abbreviated New Drug Application
Approval
075319
KETOCONAZOLE
Abbreviated New Drug Application
Approval
075331
DIFLORASONE DIACETATE
Abbreviated New Drug Application
Approval
075363
CLOBETASOL PROPIONATE
Abbreviated New Drug Application
Approval
075424
AMIODARONE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
075508
DIFLORASONE DIACETATE
Abbreviated New Drug Application
Approval
075520
NORTRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
075633
CLOBETASOL PROPIONATE (EMOLLIENT)
Abbreviated New Drug Application
Approval
075638
KETOZOLE
Abbreviated New Drug Application
Approval
075657
ENALAPRIL MALEATE
Abbreviated New Drug Application
Approval
075673
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
Abbreviated New Drug Application
Approval
075731
CLORAZEPATE DIPOTASSIUM
Abbreviated New Drug Application
Approval
075875
CARBAMAZEPINE
Abbreviated New Drug Application
Approval
075883
AMMONIUM LACTATE
Abbreviated New Drug Application
Approval
075953
TERCONAZOLE
Abbreviated New Drug Application
Approval
076005
ECONAZOLE NITRATE
Abbreviated New Drug Application
Approval
076043
TERCONAZOLE
Abbreviated New Drug Application
Approval
076174
ETODOLAC
Abbreviated New Drug Application
Approval
076216
AMMONIUM LACTATE
Abbreviated New Drug Application
Approval
076362
AMIODARONE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
076493
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
Abbreviated New Drug Application
Approval
076507
FLUCONAZOLE
Abbreviated New Drug Application
Approval
076508
BETAMETHASONE DIPROPIONATE
Abbreviated New Drug Application
Approval
076525
TERIL
Abbreviated New Drug Application
Approval
076526
FLUOROURACIL
Abbreviated New Drug Application
Approval
076543
BETAMETHASONE DIPROPIONATE
Abbreviated New Drug Application
Approval
076587
ALCLOMETASONE DIPROPIONATE
Abbreviated New Drug Application
Approval
076601
CETIRIZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
076624
MOMETASONE FUROATE
Abbreviated New Drug Application
Approval
076672
GABAPENTIN
Abbreviated New Drug Application
Approval
076679
MOMETASONE FUROATE
Abbreviated New Drug Application
Approval
076729
TERIL
Abbreviated New Drug Application
Approval
076730
ALCLOMETASONE DIPROPIONATE
Abbreviated New Drug Application
Approval
076753
BETAMETHASONE DIPROPIONATE
Abbreviated New Drug Application
Approval
076773
MICONAZOLE 3
Abbreviated New Drug Application
Approval
076788
MOMETASONE FUROATE
Abbreviated New Drug Application
Approval
076790
CICLOPIROX
Abbreviated New Drug Application
Approval
076805
LORATADINE
Abbreviated New Drug Application
Approval
076842
HYDROCORTISONE BUTYRATE
Abbreviated New Drug Application
Approval
076912
CIPROFLOXACIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
076994
HALOBETASOL PROPIONATE
Abbreviated New Drug Application
Approval
077009
ONDANSETRON HYDROCHLORIDE
Abbreviated New Drug Application
Approval
077092
CICLOPIROX
Abbreviated New Drug Application
Approval
077227
HALOBETASOL PROPIONATE
Abbreviated New Drug Application
Approval
077261
GABAPENTIN
Abbreviated New Drug Application
Approval
077278
CITALOPRAM HYDROBROMIDE
Abbreviated New Drug Application
Approval
077476
RANITIDINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
077477
BETAMETHASONE DIPROPIONATE
Abbreviated New Drug Application
Approval
077511
TERBINAFINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
077553
TERCONAZOLE
Abbreviated New Drug Application
Approval
077729
ONDANSETRON HYDROCHLORIDE
Abbreviated New Drug Application
Approval
077780
CARVEDILOL
Abbreviated New Drug Application
Approval
077801
OXCARBAZEPINE
Abbreviated New Drug Application
Approval
077819
METRONIDAZOLE
Abbreviated New Drug Application
Approval
077965
NORTRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
078072
CETIRIZINE HYDROCHLORIDE ALLERGY
CETIRIZINE HYDROCHLORIDE HIVES RELIEF
Abbreviated New Drug Application
Approval
078102
MELOXICAM
Abbreviated New Drug Application
Approval
078115
CARBAMAZEPINE
Abbreviated New Drug Application
Approval
078668
SULFACETAMIDE SODIUM
Abbreviated New Drug Application
Approval
078774
LEVETIRACETAM
Abbreviated New Drug Application
Approval
078960
LEVETIRACETAM
Abbreviated New Drug Application
Approval
079121
ESCITALOPRAM OXALATE
Abbreviated New Drug Application
Approval
079204
LAMOTRIGINE
Abbreviated New Drug Application
Approval
086154
HYDROCORTISONE
Abbreviated New Drug Application
Approval
086155
HYDROCORTISONE
Abbreviated New Drug Application
Approval
086156
NITROFURAZONE
Abbreviated New Drug Application
Approval
086256
HYDROCORTISONE
Abbreviated New Drug Application
Approval
086257
HYDROCORTISONE
Abbreviated New Drug Application
Approval
086275
TRIAMCINOLONE ACETONIDE
Abbreviated New Drug Application
Approval
086276
TRIAMCINOLONE ACETONIDE
Abbreviated New Drug Application
Approval
086277
TRIAMCINOLONE ACETONIDE
Abbreviated New Drug Application
Approval
086724
LIDOCAINE
Abbreviated New Drug Application
Approval
087102
FLUOCINOLONE ACETONIDE
Abbreviated New Drug Application
Approval
087104
FLUOCINOLONE ACETONIDE
Abbreviated New Drug Application
Approval
087902
TRIAMCINOLONE ACETONIDE
Abbreviated New Drug Application
Approval
088638
ACETIC ACID
Abbreviated New Drug Application
Approval
088759
HYDROCORTISONE AND ACETIC ACID
Abbreviated New Drug Application
Approval
088799
HYDROCORTISONE
Abbreviated New Drug Application
Approval
089024
HYDROCORTISONE
Abbreviated New Drug Application
Approval
089124
FLUOCINOLONE ACETONIDE
Abbreviated New Drug Application
Approval
089472
U-CORT
Abbreviated New Drug Application
Approval
089626
THEOPHYLLINE
Abbreviated New Drug Application
Approval
090182
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
Abbreviated New Drug Application
Approval
090269
CICLOPIROX
Abbreviated New Drug Application
Approval
090347
RISPERIDONE
Abbreviated New Drug Application
Approval
090368
FLUOROURACIL
Abbreviated New Drug Application
Approval
090817
GRANISETRON HYDROCHLORIDE
Abbreviated New Drug Application
Approval
200173
IMIQUIMOD
Abbreviated New Drug Application
Approval
200302
CLOBETASOL PROPIONATE
Abbreviated New Drug Application
Approval
200565
PHENYTOIN
Abbreviated New Drug Application
Approval
200734
FLUOCINONIDE
Abbreviated New Drug Application
Approval
200998
MEPROBAMATE
Abbreviated New Drug Application
Approval
201106
CARBAMAZEPINE
Abbreviated New Drug Application
Approval
201546
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
Abbreviated New Drug Application
Approval
201865
LORATADINE
Abbreviated New Drug Application
Approval
202161
DESONIDE
Abbreviated New Drug Application
Approval
202368
FLUOCINOLONE ACETONIDE
Abbreviated New Drug Application
Approval
202936
DESLORATADINE
Abbreviated New Drug Application
Approval
203818
DICLOFENAC SODIUM
Abbreviated New Drug Application
Approval
204141
TOPICORT
New Drug Application
Approval
New formulation
(S) Standard review drug
205076
OXICONAZOLE NITRATE
Abbreviated New Drug Application
Approval
205975
NAFTIFINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
206298
DICLOFENAC SODIUM
Abbreviated New Drug Application
Approval
206901
NAFTIFINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
208098
DICLOFENAC SODIUM
Abbreviated New Drug Application
Tentative Approval
208322
ADAPALENE
Abbreviated New Drug Application
Approval
209336
FLUOCINOLONE ACETONIDE
Abbreviated New Drug Application
Approval
Back to Companies who have applied for FDA Drug Approval