Hetero Drugs
FDA Approved Drugs

Hetero Drugs

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.

RX Unclassified
  • Total Records 27
  • Latest Approval Date May 23, 2024
  • Data Source FDA
  • First Approval Date Sep 16, 2016
All
27
View
Unclassified
18
View
RX
9
View
Company Overview

Company

Hetero Drugs

Country

India

Website

Visit Website

Email

contact@heterodrugs.com

Social Profiles

Company Snapshot

Hetero Drugs

7-2-A2, Hetero Corporate Industrial Estates, Sanath Nagar Hyderabad,Telangana

India

www.hetero.com/ contact@heterodrugs.com View on Map
FDA Approved Drug Records ( 27 records )
2016
16 Sep
RX Application: 205137

Drug Name

AMLODIPINE BESYLATE AND VALSARTAN

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;160MG

Approval Date

2016-09-16

205137 / 1

Active Ingredient

AMLODIPINE BESYLATE; VALSARTAN

Application Number

205137

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;160MG

Approval Date

2016-09-16

Regulatory Status

RX

2016
16 Sep
RX Application: 205137

Drug Name

AMLODIPINE BESYLATE AND VALSARTAN

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE;160MG

Approval Date

2016-09-16

205137 / 2

Active Ingredient

AMLODIPINE BESYLATE; VALSARTAN

Application Number

205137

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE;160MG

Approval Date

2016-09-16

Regulatory Status

RX

2016
16 Sep
RX Application: 205137

Drug Name

AMLODIPINE BESYLATE AND VALSARTAN

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE;320MG

Approval Date

2016-09-16

205137 / 3

Active Ingredient

AMLODIPINE BESYLATE; VALSARTAN

Application Number

205137

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE;320MG

Approval Date

2016-09-16

Regulatory Status

RX

2016
16 Sep
RX Application: 205137

Drug Name

AMLODIPINE BESYLATE AND VALSARTAN

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE;320MG

Approval Date

2016-09-16

205137 / 4

Active Ingredient

AMLODIPINE BESYLATE; VALSARTAN

Application Number

205137

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE;320MG

Approval Date

2016-09-16

Regulatory Status

RX

-
Unclassified Application: 219062

Drug Name

AZILSARTAN MEDOXOMIL

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

-

219062 / 1

Active Ingredient

AZILSARTAN MEDOXOMIL

Application Number

219062

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 219062

Drug Name

AZILSARTAN MEDOXOMIL

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

-

219062 / 2

Active Ingredient

AZILSARTAN MEDOXOMIL

Application Number

219062

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 219062

Drug Name

AZILSARTAN MEDOXOMIL

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

-

219062 / 3

Active Ingredient

AZILSARTAN MEDOXOMIL

Application Number

219062

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 219271

Drug Name

CYCLOPHOSPHAMIDE

Product Number

2

Dosage Form

-

Strength

500MG/2.5ML

Approval Date

-

219271 / 2

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

219271

Product Number

2

Dosage Form

-

Strength

500MG/2.5ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 219271

Drug Name

CYCLOPHOSPHAMIDE

Product Number

3

Dosage Form

-

Strength

2000MG/10ML

Approval Date

-

219271 / 3

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

219271

Product Number

3

Dosage Form

-

Strength

2000MG/10ML

Approval Date

-

Regulatory Status

Unclassified

2019
22 Mar
RX Application: 211944

Drug Name

DROSPIRENONE AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

3MG;0.02MG

Approval Date

2019-03-22

211944 / 1

Active Ingredient

DROSPIRENONE; ETHINYL ESTRADIOL

Application Number

211944

Product Number

1

Dosage Form

-

Strength

3MG;0.02MG

Approval Date

2019-03-22

Regulatory Status

RX

2020
24 Jan
RX Application: 213034

Drug Name

DROSPIRENONE AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

3MG;0.03MG

Approval Date

2020-01-24

213034 / 1

Active Ingredient

DROSPIRENONE; ETHINYL ESTRADIOL

Application Number

213034

Product Number

1

Dosage Form

-

Strength

3MG;0.03MG

Approval Date

2020-01-24

Regulatory Status

RX

-
Unclassified Application: 204119

Drug Name

EFAVIRENZ, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE

Product Number

1

Dosage Form

-

Strength

600MG;300MG;300MG

Approval Date

-

204119 / 1

Active Ingredient

EFAVIRENZ;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE

Application Number

204119

Product Number

1

Dosage Form

-

Strength

600MG;300MG;300MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 217690

Drug Name

ELAGOLIX

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

-

217690 / 2

Active Ingredient

ELAGOLIX

Application Number

217690

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 22479

Drug Name

LAMIVUDINE AND STAVUDINE

Product Number

1

Dosage Form

-

Strength

150MG/30MG

Approval Date

-

22479 / 1

Active Ingredient

LAMIVUDINE; STAVUDINE

Application Number

22479

Product Number

1

Dosage Form

-

Strength

150MG/30MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 200244

Drug Name

LAMIVUDINE, NEVIRAPINE, AND STAVUDINE

Product Number

1

Dosage Form

-

Strength

150MG; 200MG; 30MG

Approval Date

-

200244 / 1

Active Ingredient

LAMIVUDINE; NEVIRAPINE; STAVUDINE

Application Number

200244

Product Number

1

Dosage Form

-

Strength

150MG; 200MG; 30MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 22356

Drug Name

LAMIVUDINE, ZIDOVUDINE TABS 150MG/300MG CO-PACKAGED WITH NEVIRAPINE TABS 200MG

Product Number

1

Dosage Form

-

Strength

150MG; 300MG; 200MG

Approval Date

-

22356 / 1

Active Ingredient

LAMIVUDINE; ZIDOVUDINE; NEVIRAPINE

Application Number

22356

Product Number

1

Dosage Form

-

Strength

150MG; 300MG; 200MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 22459

Drug Name

LAMIVUDINE/TENOFOVIR DISOPROXIL FUMARATE FDC TABS

Product Number

1

Dosage Form

-

Strength

300MG/300MG

Approval Date

-

22459 / 1

Active Ingredient

LAMIVUDINE; TENOFOVIR

Application Number

22459

Product Number

1

Dosage Form

-

Strength

300MG/300MG

Approval Date

-

Regulatory Status

Unclassified

2023
13 Feb
RX Application: 212298

Drug Name

LEVONORGESTREL AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.02MG;0.1MG

Approval Date

2023-02-13

212298 / 1

Active Ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Application Number

212298

Product Number

1

Dosage Form

-

Strength

0.02MG;0.1MG

Approval Date

2023-02-13

Regulatory Status

RX

2022
31 Oct
RX Application: 211813

Drug Name

LINEZOLID

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2022-10-31

211813 / 1

Active Ingredient

LINEZOLID

Application Number

211813

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2022-10-31

Regulatory Status

RX

-
Unclassified Application: 219142

Drug Name

LUMATEPERONE TOSYLATE

Product Number

2

Dosage Form

-

Strength

21MG

Approval Date

-

219142 / 2

Active Ingredient

LUMATEPERONE TOSYLATE

Application Number

219142

Product Number

2

Dosage Form

-

Strength

21MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 219142

Drug Name

LUMATEPERONE TOSYLATE

Product Number

3

Dosage Form

-

Strength

42MG

Approval Date

-

219142 / 3

Active Ingredient

LUMATEPERONE TOSYLATE

Application Number

219142

Product Number

3

Dosage Form

-

Strength

42MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 219142

Drug Name

LUMATEPERONE TOSYLATE

Product Number

4

Dosage Form

-

Strength

14MG

Approval Date

-

219142 / 4

Active Ingredient

LUMATEPERONE TOSYLATE

Application Number

219142

Product Number

4

Dosage Form

-

Strength

14MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 219142

Drug Name

LUMATEPERONE TOSYLATE

Product Number

5

Dosage Form

-

Strength

28MG

Approval Date

-

219142 / 5

Active Ingredient

LUMATEPERONE TOSYLATE

Application Number

219142

Product Number

5

Dosage Form

-

Strength

28MG

Approval Date

-

Regulatory Status

Unclassified

2024
23 May
RX Application: 215024

Drug Name

MELPHALAN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/VIAL

Approval Date

2024-05-23

215024 / 1

Active Ingredient

MELPHALAN HYDROCHLORIDE

Application Number

215024

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/VIAL

Approval Date

2024-05-23

Regulatory Status

RX

-
Unclassified Application: 218654

Drug Name

SOLRIAMFETOL

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

-

218654 / 1

Active Ingredient

SOLRIAMFETOL

Application Number

218654

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 218654

Drug Name

SOLRIAMFETOL

Product Number

2

Dosage Form

-

Strength

75MG

Approval Date

-

218654 / 2

Active Ingredient

SOLRIAMFETOL

Application Number

218654

Product Number

2

Dosage Form

-

Strength

75MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 218654

Drug Name

SOLRIAMFETOL

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

-

218654 / 3

Active Ingredient

SOLRIAMFETOL

Application Number

218654

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

-

Regulatory Status

Unclassified

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Drug Status Breakdown
27 total
  • RX
  • 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

AMLODIPINE BESYLATE AND VALSARTAN

Application Number

205137

Product Number

1

Active Ingredient

AMLODIPINE BESYLATE; VALSARTAN

Dosage Form

-

Strength

EQ 5MG BASE;160MG

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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