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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022502
Company: GALDERMA LABS LP

Summary Review

Products on NDA 022502

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIFFERIN	ADAPALENE	0.1%	LOTION;TOPICAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022502

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/17/2010	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022502lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022502s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022502_differin_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022502s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/19/2023	SUPPL-10	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022502s010PI.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022502Orig1s010ltr.pdf
08/24/2022	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022502s008lbl.pdf
09/30/2014	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
05/29/2014	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
04/19/2013	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022502s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022502Orig1s003ltr.pdf

Labels for NDA 022502

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/19/2023	SUPPL-10	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022502s010PI.pdf
08/24/2022	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022502s008lbl.pdf
04/19/2013	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022502s003lbl.pdf
03/17/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022502lbl.pdf

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