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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021398
Company: ABBVIE

Summary Review

Products on NDA 021398

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COMBIGAN	BRIMONIDINE TARTRATE; TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021398

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/30/2007	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Letter (PDF) Review Summary Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021398s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021398s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021398s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/15/2015	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021398s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021398Orig1s007ltr.pdf
10/11/2012	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021398s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021398Orig1s006ltr.pdf

Labels for NDA 021398

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/15/2015	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021398s007lbl.pdf
10/11/2012	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021398s006lbl.pdf

Therapeutic Equivalents for NDA 021398

COMBIGAN

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	201949	FLORIDA
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	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	215598	UPSHER SMITH LABS
COMBIGAN	BRIMONIDINE TARTRATE; TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AB	021398	ABBVIE

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