Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020490
Company: ALLERGAN
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
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.

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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