Alembic Pharmaceuticals Limited OTC
FDA Approved Drugs

Alembic Pharmaceuticals Limited OTC

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.

OTC
  • Total Records 4
  • Latest Approval Date Oct 02, 2024
  • Data Source FDA
  • First Approval Date Dec 07, 2018
All
533
View
Unclassified
10
View
Discontinued
28
View
OTC
4
View
RX
491
View
Company Overview

Company

Alembic Pharmaceuticals Limited OTC

Country

India

Social Profiles

LinkedIn
Company Snapshot

Alembic Pharmaceuticals Limited OTC

Alembic Road, Vadodara - 390 003, Gujarat

India

www.alembic-india.com/ infoal@alembic.co.in View on Map
FDA Approved Drug Records ( 4 records )
2024
02 Oct
OTC Application: 209290

Drug Name

ALCAFTADINE

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

2024-10-02

209290 / 1

Active Ingredient

ALCAFTADINE

Application Number

209290

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

2024-10-02

Regulatory Status

OTC

2022
03 May
OTC Application: 215839

Drug Name

DOCOSANOL

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

2022-05-03

215839 / 1

Active Ingredient

DOCOSANOL

Application Number

215839

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

2022-05-03

Regulatory Status

OTC

2019
29 Apr
OTC Application: 209420

Drug Name

OLOPATADINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.2% BASE

Approval Date

2019-04-29

209420 / 1

Active Ingredient

OLOPATADINE HYDROCHLORIDE

Application Number

209420

Product Number

1

Dosage Form

-

Strength

EQ 0.2% BASE

Approval Date

2019-04-29

Regulatory Status

OTC

2018
07 Dec
OTC Application: 209919

Drug Name

OLOPATADINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

2018-12-07

209919 / 1

Active Ingredient

OLOPATADINE HYDROCHLORIDE

Application Number

209919

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

2018-12-07

Regulatory Status

OTC

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Drug Status Breakdown
4 total
  • OTC
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

ALCAFTADINE

Application Number

209290

Product Number

1

Active Ingredient

ALCAFTADINE

Dosage Form

-

Strength

0.25%

FDA Approved Drug Data

Approved drug product information

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Data maintained from official sources

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