Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021056
Company: BAUSCH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TARGRETIN BEXAROTENE 1% GEL;TOPICAL 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
06/28/2000 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21056ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-056_Targretin.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/09/2015 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/22/2013 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/08/2011 SUPPL-3 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021056s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021056s003ltr.pdf
03/14/2002 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/08/2011 SUPPL-3 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021056s003lbl.pdf
06/28/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21056lbl.pdf

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