Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020748
Company: GALDERMA LABS LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIFFERIN ADAPALENE 0.1% CREAM;TOPICAL Prescription AB 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
05/26/2000 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20748lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20748ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020748_differin.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/01/2014 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/08/2013 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/25/2001 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
05/26/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20748lbl.pdf

DIFFERIN

CREAM;TOPICAL; 0.1%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ADAPALENE ADAPALENE 0.1% CREAM;TOPICAL Prescription No AB 090824 FOUGERA PHARMS
DIFFERIN ADAPALENE 0.1% CREAM;TOPICAL Prescription Yes AB 020748 GALDERMA LABS LP

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