Hetero Drugs RX
FDA Approved Drugs

Hetero Drugs RX

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

Company

Hetero Drugs RX

Country

India

Website

Visit Website

Email

contact@heterodrugs.com

Social Profiles

Company Snapshot

Hetero Drugs RX

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 ( 9 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

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

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

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

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Drug Status Breakdown
9 total
  • RX
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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