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Drugs@FDA: FDA-Approved Drugs

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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.cfm

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	TARO
DIFFERIN	ADAPALENE	0.3%	GEL;TOPICAL	Prescription	Yes	AB	021753	GALDERMA LABS LP

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