Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021398
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
COMBIGAN BRIMONIDINE TARTRATE; TIMOLOL MALEATE 0.2%;EQ 0.5% BASE 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
10/30/2007 ORIG-1 Approval Type 4 - New Combination STANDARD Letter (PDF)
Review
Summary Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021398s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021398s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021398s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/15/2015 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021398s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021398Orig1s007ltr.pdf
10/11/2012 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021398s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021398Orig1s006ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/15/2015 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021398s007lbl.pdf
10/11/2012 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021398s006lbl.pdf

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