QOLIANA | 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

CPhI China

Attending

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

India

RLD : No

TE Code : AB

Brand Name : BRIMONIDINE TARTRATE

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : 0.1%

Approval Date : 2026-04-16

Application Number : 220398

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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

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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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