An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021753
Company: GALDERMA LABS LP

Products on NDA 021753

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIFFERIN	ADAPALENE	0.3%	GEL;TOPICAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021753

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/19/2007	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021753lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021753s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021753TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/27/2023	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021753s014s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021753Orig1s014, s018ltr.pdf
12/27/2023	SUPPL-14	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021753s014s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021753Orig1s014, s018ltr.pdf
08/25/2022	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021753s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021753Orig1s011ltr.pdf
06/13/2014	SUPPL-7	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021753Orig1s007ltr.pdf
02/27/2012	SUPPL-4	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021753s004lbl.pdf
09/01/2010	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021753s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021753s002ltr.pdf

Labels for NDA 021753

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/27/2023	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021753s014s018lbl.pdf
12/27/2023	SUPPL-14	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021753s014s018lbl.pdf
08/25/2022	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021753s011lbl.pdf
02/27/2012	SUPPL-4	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021753s004lbl.pdf
09/01/2010	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021753s002lbl.pdf
06/19/2007	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021753lbl.pdf

Therapeutic Equivalents for NDA 021753

DIFFERIN

GEL;TOPICAL; 0.3%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ADAPALENE	ADAPALENE	0.3%	GEL;TOPICAL	Prescription	No	AB	201000	ACTAVIS MID ATLANTIC
ADAPALENE	ADAPALENE	0.3%	GEL;TOPICAL	Prescription	No	AB	213508	ALEMBIC
ADAPALENE	ADAPALENE	0.3%	GEL;TOPICAL	Prescription	No	AB	200298	ENCUBE ETHICALS
ADAPALENE	ADAPALENE	0.3%	GEL;TOPICAL	Prescription	No	AB	208322	SUN PHARMA CANADA
DIFFERIN	ADAPALENE	0.3%	GEL;TOPICAL	Prescription	Yes	AB	021753	GALDERMA LABS LP

Top