Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020380
Company: GALDERMA LABS LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIFFERIN ADAPALENE 0.1% GEL;TOPICAL Over-the-counter 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
05/31/1996 ORIG-1 Approval Type 3 - New Dosage Form 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
03/23/2018 SUPPL-13 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020380Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020380Orig1s013ltr.pdf
05/19/2017 SUPPL-11 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020380Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020380Orig1s011ltr.pdf
07/08/2016 SUPPL-10 Efficacy-Rx To OTC Switch Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020380Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020380Orig1s010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/020380s10_toc.cfm
09/05/2007 SUPPL-4 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/23/2018 SUPPL-13 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020380Orig1s013lbl.pdf
05/19/2017 SUPPL-11 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020380Orig1s011lbl.pdf
07/08/2016 SUPPL-10 Efficacy-Rx To OTC Switch Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020380Orig1s010lbl.pdf

DIFFERIN

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

GEL;TOPICAL; 0.1%
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ADAPALENE ADAPALENE 0.1% GEL;TOPICAL Over-the-counter No 091314 GLENMARK GENERICS
DIFFERIN ADAPALENE 0.1% GEL;TOPICAL Over-the-counter Yes 020380 GALDERMA LABS LP

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