Unichem Laboratories Limited
FDA Approved Drugs

Unichem Laboratories Limited

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 RX
  • Total Records 20
  • Latest Approval Date Feb 19, 2013
  • Data Source FDA
  • First Approval Date Mar 27, 2009
All
20
View
Unclassified
7
View
RX
13
View
Company Overview

Company

Unichem Laboratories Limited

Country

India

Website

Visit Website

Email

unichemindia@mail.ru

Social Profiles

LinkedIn
Company Snapshot

Unichem Laboratories Limited

Unichem Bhavan Prabhat Estate, Off S.V.Road, Jogeshwari (West), Mumbai - 400 102

India

www.unichemlabs.com/ unichemindia@mail.ru View on Map
FDA Approved Drug Records ( 20 records )
-
Unclassified Application: 210108

Drug Name

APIXABAN

Product Number

2

Dosage Form

-

Strength

1.5MG

Approval Date

-

210108 / 2

Active Ingredient

APIXABAN

Application Number

210108

Product Number

2

Dosage Form

-

Strength

1.5MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 210108

Drug Name

APIXABAN

Product Number

3

Dosage Form

-

Strength

2.0MG

Approval Date

-

210108 / 3

Active Ingredient

APIXABAN

Application Number

210108

Product Number

3

Dosage Form

-

Strength

2.0MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 210108

Drug Name

APIXABAN

Product Number

4

Dosage Form

-

Strength

5MG

Approval Date

-

210108 / 4

Active Ingredient

APIXABAN

Application Number

210108

Product Number

4

Dosage Form

-

Strength

5MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 210108

Drug Name

APIXABAN

Product Number

5

Dosage Form

-

Strength

2.5MG

Approval Date

-

210108 / 5

Active Ingredient

APIXABAN

Application Number

210108

Product Number

5

Dosage Form

-

Strength

2.5MG

Approval Date

-

Regulatory Status

Unclassified

2011
05 Apr
RX Application: 79163

Drug Name

DIVALPROEX SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 125MG VALPROIC ACID

Approval Date

2011-04-05

79163 / 1

Active Ingredient

DIVALPROEX SODIUM

Application Number

79163

Product Number

1

Dosage Form

-

Strength

EQ 125MG VALPROIC ACID

Approval Date

2011-04-05

Regulatory Status

RX

2011
05 Apr
RX Application: 79163

Drug Name

DIVALPROEX SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 250MG VALPROIC ACID

Approval Date

2011-04-05

79163 / 2

Active Ingredient

DIVALPROEX SODIUM

Application Number

79163

Product Number

2

Dosage Form

-

Strength

EQ 250MG VALPROIC ACID

Approval Date

2011-04-05

Regulatory Status

RX

2011
05 Apr
RX Application: 79163

Drug Name

DIVALPROEX SODIUM

Product Number

3

Dosage Form

-

Strength

EQ 500MG VALPROIC ACID

Approval Date

2011-04-05

79163 / 3

Active Ingredient

DIVALPROEX SODIUM

Application Number

79163

Product Number

3

Dosage Form

-

Strength

EQ 500MG VALPROIC ACID

Approval Date

2011-04-05

Regulatory Status

RX

2011
06 Oct
RX Application: 90170

Drug Name

LAMOTRIGINE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2011-10-06

90170 / 1

Active Ingredient

LAMOTRIGINE

Application Number

90170

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2011-10-06

Regulatory Status

RX

2011
06 Oct
RX Application: 90170

Drug Name

LAMOTRIGINE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2011-10-06

90170 / 2

Active Ingredient

LAMOTRIGINE

Application Number

90170

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2011-10-06

Regulatory Status

RX

2011
06 Oct
RX Application: 90170

Drug Name

LAMOTRIGINE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2011-10-06

90170 / 3

Active Ingredient

LAMOTRIGINE

Application Number

90170

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2011-10-06

Regulatory Status

RX

2011
06 Oct
RX Application: 90170

Drug Name

LAMOTRIGINE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2011-10-06

90170 / 4

Active Ingredient

LAMOTRIGINE

Application Number

90170

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2011-10-06

Regulatory Status

RX

-
Unclassified Application: 214693

Drug Name

SITAGLIPTIN PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

-

214693 / 1

Active Ingredient

SITAGLIPTIN PHOSPHATE

Application Number

214693

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 214693

Drug Name

SITAGLIPTIN PHOSPHATE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

-

214693 / 2

Active Ingredient

SITAGLIPTIN PHOSPHATE

Application Number

214693

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 214693

Drug Name

SITAGLIPTIN PHOSPHATE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

-

214693 / 3

Active Ingredient

SITAGLIPTIN PHOSPHATE

Application Number

214693

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

-

Regulatory Status

Unclassified

2012
28 Nov
RX Application: 91283

Drug Name

TIZANIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2012-11-28

91283 / 1

Active Ingredient

TIZANIDINE HYDROCHLORIDE

Application Number

91283

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2012-11-28

Regulatory Status

RX

2012
28 Nov
RX Application: 91283

Drug Name

TIZANIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2012-11-28

91283 / 2

Active Ingredient

TIZANIDINE HYDROCHLORIDE

Application Number

91283

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2012-11-28

Regulatory Status

RX

2009
27 Mar
RX Application: 90162

Drug Name

TOPIRAMATE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2009-03-27

90162 / 1

Active Ingredient

TOPIRAMATE

Application Number

90162

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2009-03-27

Regulatory Status

RX

2009
27 Mar
RX Application: 90162

Drug Name

TOPIRAMATE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2009-03-27

90162 / 2

Active Ingredient

TOPIRAMATE

Application Number

90162

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2009-03-27

Regulatory Status

RX

2009
27 Mar
RX Application: 90162

Drug Name

TOPIRAMATE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2009-03-27

90162 / 3

Active Ingredient

TOPIRAMATE

Application Number

90162

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2009-03-27

Regulatory Status

RX

2013
19 Feb
RX Application: 90162

Drug Name

TOPIRAMATE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2013-02-19

90162 / 4

Active Ingredient

TOPIRAMATE

Application Number

90162

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2013-02-19

Regulatory Status

RX

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Drug Status Breakdown
20 total
  • Unclassified
  • 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

APIXABAN

Application Number

210108

Product Number

2

Active Ingredient

APIXABAN

Dosage Form

-

Strength

1.5MG

FDA Approved Drug Data

Approved drug product information

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Data maintained from official sources

Structured Database

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Reliable Data

Organized FDA drug records

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