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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021262
Company: ABBVIE

Products on NDA 021262

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALPHAGAN P	BRIMONIDINE TARTRATE	0.15%	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021262

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/16/2001	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-262_Alphagan%20P%20Ophthalmic_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-262_Alphagan%20P%20Ophthalmic_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-262_AlphaganP.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/19/2014	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
08/13/2010	SUPPL-20	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
05/22/2006	SUPPL-18	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021262s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021262s018LTR.pdf
02/10/2004	SUPPL-13	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21262slcp010,slr013ltr.pdf
02/10/2004	SUPPL-10	Manufacturing (CMC)-Packaging	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21262slcp010,slr013ltr.pdf
04/12/2002	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
06/19/2002	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
01/22/2002	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
12/20/2001	SUPPL-6	Efficacy-New Patient Population	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21262s6lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-490S007_Brimonidine%20Tartrate%20Ophthalmic_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-490s007_Alphagan.cfm
12/04/2001	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
12/18/2001	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
10/15/2001	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
06/05/2001	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
10/23/2001	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 021262

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/13/2010	SUPPL-20	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021262s020,021770s004lbl.pdf
05/22/2006	SUPPL-18	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021262s018lbl.pdf
12/20/2001	SUPPL-6	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21262s6lbl.pdf
03/16/2001	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-262_Alphagan%20P%20Ophthalmic_prntlbl.pdf

Therapeutic Equivalents for NDA 021262

ALPHAGAN P

SOLUTION/DROPS;OPHTHALMIC; 0.15%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALPHAGAN P	BRIMONIDINE TARTRATE	0.15%	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AT	021262	ABBVIE
BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	0.15%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	215225	ALEMBIC
BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	0.15%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	078479	APOTEX
BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	0.15%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	216772	UPSHER SMITH LABS
QOLIANA	BRIMONIDINE TARTRATE	0.15%	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AT	021764	SANDOZ

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