Teva Pharmaceutical Industries Unclassified
FDA Approved Drugs

Teva Pharmaceutical Industries Unclassified

FDA Approved Drugs Database

FDA approved drug product records including application numbers, product numbers, drug names, active ingredients, dosage forms, strengths, approval dates and regulatory status.

Unclassified
  • Total Records 80
  • Latest Approval Date -
  • Data Source FDA
  • First Approval Date -
All
831
View
Unclassified
80
View
Discontinued
412
View
OTC
1
View
RX
338
View
Company Overview

Company

Teva Pharmaceutical Industries Unclassified

Country

Israel

Website

Visit Website

Email

Social Profiles

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Company Snapshot

Teva Pharmaceutical Industries Unclassified

5 Basel St., Petach Tikva Israel, 49131

Israel

www.tevapharm.com/ View on Map
FDA Approved Drug Records ( 80 records )
-
Unclassified Application: 761089

Drug Name

AJOVY

Product Number

1

Dosage Form

-

Strength

150MG/ML

Approval Date

-

761089 / 1

Active Ingredient

FREMANEZUMAB-VFRM

Application Number

761089

Product Number

1

Dosage Form

-

Strength

150MG/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 210142

Drug Name

APIXABAN

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

-

210142 / 1

Active Ingredient

APIXABAN

Application Number

210142

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 200152

Drug Name

ARMODAFINIL

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

-

200152 / 1

Active Ingredient

ARMODAFINIL

Application Number

200152

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 200152

Drug Name

ARMODAFINIL

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

-

200152 / 2

Active Ingredient

ARMODAFINIL

Application Number

200152

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 200152

Drug Name

ARMODAFINIL

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

-

200152 / 3

Active Ingredient

ARMODAFINIL

Application Number

200152

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 200152

Drug Name

ARMODAFINIL

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

-

200152 / 4

Active Ingredient

ARMODAFINIL

Application Number

200152

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 200152

Drug Name

ARMODAFINIL

Product Number

5

Dosage Form

-

Strength

250MG

Approval Date

-

200152 / 5

Active Ingredient

ARMODAFINIL

Application Number

200152

Product Number

5

Dosage Form

-

Strength

250MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 78729

Drug Name

ARSENIC TRIOXIDE

Product Number

1

Dosage Form

-

Strength

10ML

Approval Date

-

78729 / 1

Active Ingredient

ARSENIC TRIOXIDE

Application Number

78729

Product Number

1

Dosage Form

-

Strength

10ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 209791

Drug Name

ASPIRIN; OMEPRAZOLE

Product Number

1

Dosage Form

-

Strength

81MG;40MG

Approval Date

-

209791 / 1

Active Ingredient

ASPIRIN;OMEPRAZOLE

Application Number

209791

Product Number

1

Dosage Form

-

Strength

81MG;40MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 209791

Drug Name

ASPIRIN; OMEPRAZOLE

Product Number

2

Dosage Form

-

Strength

325MG;40MG

Approval Date

-

209791 / 2

Active Ingredient

ASPIRIN;OMEPRAZOLE

Application Number

209791

Product Number

2

Dosage Form

-

Strength

325MG;40MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 209885

Drug Name

AUSTEDO

Product Number

1

Dosage Form

-

Strength

6MG

Approval Date

-

209885 / 1

Active Ingredient

DEUTETRABENAZINE

Application Number

209885

Product Number

1

Dosage Form

-

Strength

6MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 209885

Drug Name

AUSTEDO

Product Number

2

Dosage Form

-

Strength

9MG

Approval Date

-

209885 / 2

Active Ingredient

DEUTETRABENAZINE

Application Number

209885

Product Number

2

Dosage Form

-

Strength

9MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 209885

Drug Name

AUSTEDO

Product Number

3

Dosage Form

-

Strength

12MG

Approval Date

-

209885 / 3

Active Ingredient

DEUTETRABENAZINE

Application Number

209885

Product Number

3

Dosage Form

-

Strength

12MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 210234

Drug Name

AXITINIB

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

-

210234 / 1

Active Ingredient

AXITINIB

Application Number

210234

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 210234

Drug Name

AXITINIB

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

-

210234 / 2

Active Ingredient

AXITINIB

Application Number

210234

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 210451

Drug Name

CANAGLIFLOZIN

Product Number

2

Dosage Form

-

Strength

300mg

Approval Date

-

210451 / 2

Active Ingredient

CANAGLIFLOZIN

Application Number

210451

Product Number

2

Dosage Form

-

Strength

300mg

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 200887

Drug Name

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

16MG; 12.5MG

Approval Date

-

200887 / 1

Active Ingredient

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Application Number

200887

Product Number

1

Dosage Form

-

Strength

16MG; 12.5MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 200887

Drug Name

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

32MG; 12.5MG

Approval Date

-

200887 / 2

Active Ingredient

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Application Number

200887

Product Number

2

Dosage Form

-

Strength

32MG; 12.5MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 200887

Drug Name

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

32MG; 25MG

Approval Date

-

200887 / 3

Active Ingredient

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Application Number

200887

Product Number

3

Dosage Form

-

Strength

32MG; 25MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 78746

Drug Name

CARBAMAZEPINE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

-

78746 / 1

Active Ingredient

CARBAMAZEPINE

Application Number

78746

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 78746

Drug Name

CARBAMAZEPINE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

-

78746 / 2

Active Ingredient

CARBAMAZEPINE

Application Number

78746

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 78746

Drug Name

CARBAMAZEPINE

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

-

78746 / 3

Active Ingredient

CARBAMAZEPINE

Application Number

78746

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 90539

Drug Name

CINACALCET HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

-

90539 / 1

Active Ingredient

CINACALCET HYDROCHLORIDE

Application Number

90539

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 208057

Drug Name

DABIGATRAN ETEXILATE MESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

-

208057 / 1

Active Ingredient

DABIGATRAN ETEXILATE MESYLATE

Application Number

208057

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 208057

Drug Name

DABIGATRAN ETEXILATE MESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 110MG BASE

Approval Date

-

208057 / 2

Active Ingredient

DABIGATRAN ETEXILATE MESYLATE

Application Number

208057

Product Number

2

Dosage Form

-

Strength

EQ 110MG BASE

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 208057

Drug Name

DABIGATRAN ETEXILATE MESYLATE

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

-

208057 / 3

Active Ingredient

DABIGATRAN ETEXILATE MESYLATE

Application Number

208057

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 206854

Drug Name

DALFAMPRIDINE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

-

206854 / 1

Active Ingredient

DALFAMPRIDINE

Application Number

206854

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 202118

Drug Name

DARUNAVIR

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

-

202118 / 2

Active Ingredient

DARUNAVIR

Application Number

202118

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 202118

Drug Name

DARUNAVIR

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

-

202118 / 3

Active Ingredient

DARUNAVIR

Application Number

202118

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 202118

Drug Name

DARUNAVIR

Product Number

4

Dosage Form

-

Strength

600MG

Approval Date

-

202118 / 4

Active Ingredient

DARUNAVIR

Application Number

202118

Product Number

4

Dosage Form

-

Strength

600MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 206555

Drug Name

DARUNAVIR

Product Number

1

Dosage Form

-

Strength

800MG

Approval Date

-

206555 / 1

Active Ingredient

DARUNAVIR

Application Number

206555

Product Number

1

Dosage Form

-

Strength

800MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 202731

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

30MG

Approval Date

-

202731 / 5

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

202731

Product Number

5

Dosage Form

-

Strength

30MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 91175

Drug Name

EFAVIRENZ

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

-

91175 / 1

Active Ingredient

EFAVIRENZ

Application Number

91175

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 77412

Drug Name

ESCITALOPRAM OXALATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

-

77412 / 1

Active Ingredient

ESCITALOPRAM OXALATE

Application Number

77412

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 77412

Drug Name

ESCITALOPRAM OXALATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

-

77412 / 2

Active Ingredient

ESCITALOPRAM OXALATE

Application Number

77412

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 77412

Drug Name

ESCITALOPRAM OXALATE

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

-

77412 / 3

Active Ingredient

ESCITALOPRAM OXALATE

Application Number

77412

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 211350

Drug Name

IBRUTINIB

Product Number

1

Dosage Form

-

Strength

140MG

Approval Date

-

211350 / 1

Active Ingredient

IBRUTINIB

Application Number

211350

Product Number

1

Dosage Form

-

Strength

140MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 204999

Drug Name

LACOSAMIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

-

204999 / 1

Active Ingredient

LACOSAMIDE

Application Number

204999

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 204999

Drug Name

LACOSAMIDE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

-

204999 / 2

Active Ingredient

LACOSAMIDE

Application Number

204999

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 204999

Drug Name

LACOSAMIDE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

-

204999 / 3

Active Ingredient

LACOSAMIDE

Application Number

204999

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 204999

Drug Name

LACOSAMIDE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

-

204999 / 4

Active Ingredient

LACOSAMIDE

Application Number

204999

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 78636

Drug Name

LAMIVUDINE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

-

78636 / 1

Active Ingredient

LAMIVUDINE

Application Number

78636

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 78636

Drug Name

LAMIVUDINE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

-

78636 / 2

Active Ingredient

LAMIVUDINE

Application Number

78636

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 214202

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

-

214202 / 1

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

214202

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 214202

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

-

214202 / 2

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

214202

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 214202

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

-

214202 / 3

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

214202

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 76596

Drug Name

MODAFINIL

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

-

76596 / 1

Active Ingredient

MODAFINIL

Application Number

76596

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 76596

Drug Name

MODAFINIL

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

-

76596 / 2

Active Ingredient

MODAFINIL

Application Number

76596

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 78073

Drug Name

MOXIFLOXACIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

-

78073 / 1

Active Ingredient

MOXIFLOXACIN HYDROCHLORIDE

Application Number

78073

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 211812

Drug Name

OXYMETAZOLINE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

-

211812 / 1

Active Ingredient

OXYMETAZOLINE

Application Number

211812

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 91583

Drug Name

PARICALCITOL

Product Number

1

Dosage Form

-

Strength

2MCG/ML

Approval Date

-

91583 / 1

Active Ingredient

PARICALCITOL

Application Number

91583

Product Number

1

Dosage Form

-

Strength

2MCG/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 91583

Drug Name

PARICALCITOL

Product Number

2

Dosage Form

-

Strength

5MCG/ML

Approval Date

-

91583 / 2

Active Ingredient

PARICALCITOL

Application Number

91583

Product Number

2

Dosage Form

-

Strength

5MCG/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 91583

Drug Name

PARICALCITOL

Product Number

3

Dosage Form

-

Strength

10MCG/ML

Approval Date

-

91583 / 3

Active Ingredient

PARICALCITOL

Application Number

91583

Product Number

3

Dosage Form

-

Strength

10MCG/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 90352

Drug Name

PEMETREXED

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

-

90352 / 1

Active Ingredient

PEMETREXED SODIUM

Application Number

90352

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 214750

Drug Name

PIMAVANSERIN

Product Number

1

Dosage Form

-

Strength

EQ 34MG BASE

Approval Date

-

214750 / 1

Active Ingredient

PIMAVANSERIN

Application Number

214750

Product Number

1

Dosage Form

-

Strength

EQ 34MG BASE

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 206167

Drug Name

PRALATREXATE

Product Number

1

Dosage Form

-

Strength

20MG/1ML

Approval Date

-

206167 / 1

Active Ingredient

PRALATREXATE

Application Number

206167

Product Number

1

Dosage Form

-

Strength

20MG/1ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 206167

Drug Name

PRALATREXATE

Product Number

2

Dosage Form

-

Strength

40MG/2ML

Approval Date

-

206167 / 2

Active Ingredient

PRALATREXATE

Application Number

206167

Product Number

2

Dosage Form

-

Strength

40MG/2ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 71995

Drug Name

PRAZOSIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

-

71995 / 1

Active Ingredient

PRAZOSIN HYDROCHLORIDE

Application Number

71995

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 208174

Drug Name

RANOLAZINE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

-

208174 / 1

Active Ingredient

RANOLAZINE

Application Number

208174

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 208174

Drug Name

RANOLAZINE

Product Number

2

Dosage Form

-

Strength

1000MG

Approval Date

-

208174 / 2

Active Ingredient

RANOLAZINE

Application Number

208174

Product Number

2

Dosage Form

-

Strength

1000MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 77611

Drug Name

RIBAVIRIN

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

-

77611 / 1

Active Ingredient

RIBAVIRIN

Application Number

77611

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 211044

Drug Name

RIOCIGUAT

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

-

211044 / 2

Active Ingredient

RIOCIGUAT

Application Number

211044

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 211044

Drug Name

RIOCIGUAT

Product Number

3

Dosage Form

-

Strength

1.5MG

Approval Date

-

211044 / 3

Active Ingredient

RIOCIGUAT

Application Number

211044

Product Number

3

Dosage Form

-

Strength

1.5MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 211044

Drug Name

RIOCIGUAT

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

-

211044 / 4

Active Ingredient

RIOCIGUAT

Application Number

211044

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 211044

Drug Name

RIOCIGUAT

Product Number

5

Dosage Form

-

Strength

2.5MG

Approval Date

-

211044 / 5

Active Ingredient

RIOCIGUAT

Application Number

211044

Product Number

5

Dosage Form

-

Strength

2.5MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 76532

Drug Name

SIMVASTATIN

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

-

76532 / 1

Active Ingredient

SIMVASTATIN

Application Number

76532

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 76532

Drug Name

SIMVASTATIN

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

-

76532 / 2

Active Ingredient

SIMVASTATIN

Application Number

76532

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 76532

Drug Name

SIMVASTATIN

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

-

76532 / 3

Active Ingredient

SIMVASTATIN

Application Number

76532

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 76532

Drug Name

SIMVASTATIN

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

-

76532 / 4

Active Ingredient

SIMVASTATIN

Application Number

76532

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 76532

Drug Name

SIMVASTATIN

Product Number

5

Dosage Form

-

Strength

80MG

Approval Date

-

76532 / 5

Active Ingredient

SIMVASTATIN

Application Number

76532

Product Number

5

Dosage Form

-

Strength

80MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 202487

Drug Name

SITAGLIPTIN PHOSPHATE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

-

202487 / 1

Active Ingredient

SITAGLIPTIN PHOSPHATE

Application Number

202487

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 202487

Drug Name

SITAGLIPTIN PHOSPHATE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

-

202487 / 2

Active Ingredient

SITAGLIPTIN PHOSPHATE

Application Number

202487

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 202487

Drug Name

SITAGLIPTIN PHOSPHATE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

-

202487 / 3

Active Ingredient

SITAGLIPTIN PHOSPHATE

Application Number

202487

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 204591

Drug Name

SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG;500MG

Approval Date

-

204591 / 1

Active Ingredient

SITAGLIPTIN PHOSPHATE;METFORMIN HYDROCHLORIDE

Application Number

204591

Product Number

1

Dosage Form

-

Strength

50MG;500MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 204591

Drug Name

SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

50MG;1000MG

Approval Date

-

204591 / 2

Active Ingredient

SITAGLIPTIN PHOSPHATE;METFORMIN HYDROCHLORIDE

Application Number

204591

Product Number

2

Dosage Form

-

Strength

50MG;1000MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 204591

Drug Name

SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

100MG;1000MG

Approval Date

-

204591 / 3

Active Ingredient

SITAGLIPTIN PHOSPHATE;METFORMIN HYDROCHLORIDE

Application Number

204591

Product Number

3

Dosage Form

-

Strength

100MG;1000MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 209813

Drug Name

TOFACITINIB CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 11MG BASE

Approval Date

-

209813 / 1

Active Ingredient

TOFACITINIB CITRATE

Application Number

209813

Product Number

1

Dosage Form

-

Strength

EQ 11MG BASE

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 209813

Drug Name

TOFACITINIB CITRATE

Product Number

2

Dosage Form

-

Strength

EQ 22MG BASE

Approval Date

-

209813 / 2

Active Ingredient

TOFACITINIB CITRATE

Application Number

209813

Product Number

2

Dosage Form

-

Strength

EQ 22MG BASE

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 201920

Drug Name

VARENICLINE

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

-

201920 / 1

Active Ingredient

VARENICLINE

Application Number

201920

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 201920

Drug Name

VARENICLINE

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

-

201920 / 2

Active Ingredient

VARENICLINE

Application Number

201920

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

-

Regulatory Status

Unclassified

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Drug Status Breakdown
80 total
  • Unclassified
Official Source

FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

Explore important FDA approved drug information available in the records above.

Drug Name

AJOVY

Application Number

761089

Product Number

1

Active Ingredient

FREMANEZUMAB-VFRM

Dosage Form

-

Strength

150MG/ML

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

Reliable Data

Organized FDA drug records

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