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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020490
Company: ALLERGAN

Products on NDA 020490

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALPHAGAN	BRIMONIDINE TARTRATE	0.5%	SOLUTION/DROPS;OPHTHALMIC	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020490

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/13/1997	ORIG-1	Approval	Type 3 - New Dosage Form	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
03/23/2016	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020490s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020490Orig1s008ltr.pdf
12/20/2001	SUPPL-7	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
04/09/2001	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
05/26/2000	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
08/26/1999	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
05/20/1998	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
02/25/1998	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
01/15/1998	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 020490

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/23/2016	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020490s008lbl.pdf
12/20/2001	SUPPL-7	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21262s6lbl.pdf

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