Brimonidine Tartrate | FDA Orange Book | Approved Drug Product List

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U.S.A

RLD : Yes

TE Code : AT

Brand Name : ALPHAGAN P

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : 0.15%

Approval Date : 2001-03-16

Application Number : 21262

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AT

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02

ALLERGAN

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U.S.A

RLD : No

TE Code :

Brand Name : ALPHAGAN

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : 0.5%

Approval Date : 1997-03-13

Application Number : 20490

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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03

DR REDDYS LABS SA

India

CPhI North America

Attending

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

India

RLD : No

TE Code :

Brand Name : BRIMONIDINE TARTRATE

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : 0.025%

Approval Date : 2024-02-16

Application Number : 216361

RX/OTC/DISCN : OTC

RLD : No

TE Code :

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04

MANKIND PHARMA

India

Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.

India

RLD :

TE Code :

Brand Name : BRIMONIDINE TARTRATE

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : 0.1%

Approval Date :

Application Number : 220398

RX/OTC/DISCN :

RLD :

TE Code :

Product Web Link

05

ABBVIE

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U.S.A

RLD : Yes

TE Code : AB

BRIMONIDINE TARTRATE; TIMOLOL MALEATE

Brand Name : COMBIGAN

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : 0.2%;EQ 0.5% BASE

Approval Date : 2007-10-30

Application Number : 21398

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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06

ABBVIE

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U.S.A

RLD : Yes

TE Code : AB

Brand Name : ALPHAGAN P

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : 0.1%

Approval Date : 2005-08-19

Application Number : 21770

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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07

ALLERGAN

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

U.S.A

RLD : Yes

TE Code :

Brand Name : ALPHAGAN

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1996-09-06

Application Number : 20613

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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