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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021770
Company: ABBVIE

Products on NDA 021770

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALPHAGAN P	BRIMONIDINE TARTRATE	0.1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021770

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/19/2005	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021770lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021770ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021770s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/18/2025	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021770s014,021262s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/021770Orig1s014, 021262Orig1s028ltr.pdf
05/05/2016	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
01/22/2014	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
03/12/2014	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
06/05/2013	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
08/13/2010	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021262s020,021770s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021262s020,021770s004ltr.pdf
04/17/2006	SUPPL-1	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021770s001ltr.pdf

Labels for NDA 021770

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/18/2025	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021770s014,021262s028lbl.pdf
08/13/2010	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021262s020,021770s004lbl.pdf
08/19/2005	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021770lbl.pdf

Therapeutic Equivalents for NDA 021770

ALPHAGAN P

SOLUTION/DROPS;OPHTHALMIC; 0.1%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALPHAGAN P	BRIMONIDINE TARTRATE	0.1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AB	021770	ABBVIE
BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	0.1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AB	216909	ALEMBIC
BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	0.1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AB	078480	APOTEX
BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	0.1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AB	219219	GLAND
BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	0.1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AB	213215	LUPIN
BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	0.1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AB	220398	MANKIND PHARMA
BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	0.1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AB	203172	SANDOZ
BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	0.1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AB	216906	SOMERSET THERAPS LLC

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