Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215230
Company: ALEMBIC

Products on ANDA 215230

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	BRIMONIDINE TARTRATE; TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215230

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/25/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/11/2026	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 215230

BRIMONIDINE TARTRATE AND TIMOLOL MALEATE

SOLUTION/DROPS;OPHTHALMIC; 0.2%;EQ 0.5% BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	BRIMONIDINE TARTRATE; TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AB	215230	ALEMBIC
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	BRIMONIDINE TARTRATE; TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AB	091442	APOTEX
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	BRIMONIDINE TARTRATE; TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AB	219093	CAPLIN
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	BRIMONIDINE TARTRATE; TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AB	219166	GLAND
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	BRIMONIDINE TARTRATE; TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AB	214987	GLENMARK PHARMS LTD
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	BRIMONIDINE TARTRATE; TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AB	201949	REGCON HOLDINGS
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	BRIMONIDINE TARTRATE; TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AB	091087	SANDOZ
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	BRIMONIDINE TARTRATE; TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AB	091086	SENTISS
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	BRIMONIDINE TARTRATE; TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AB	216114	SOMERSET
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	BRIMONIDINE TARTRATE; TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AB	215598	UPSHER SMITH LABS
COMBIGAN	BRIMONIDINE TARTRATE; TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AB	021398	ABBVIE