Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021770
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALPHAGAN P BRIMONIDINE TARTRATE 0.1% SOLUTION/DROPS;OPHTHALMIC Prescription None Yes Yes
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.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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