Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020338
Company: GALDERMA LABS LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIFFERIN ADAPALENE 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION;TOPICAL Discontinued None Yes No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
05/31/1996 ORIG-1 Approval Type 1 - New Molecular Entity 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
04/08/2002 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/10/1999 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/12/1998 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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