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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020380
Company: GALDERMA LABS LP

Products on NDA 020380

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020380

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
06/14/2022	SUPPL-21	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020380Orig1s021ltr.pdf
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-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Labels for NDA 020380

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

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

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 PHARMS INC
ADAPALENE	ADAPALENE	0.1%	GEL;TOPICAL	Over-the-counter	No	091314	GLENMARK PHARMS INC
ADAPALENE	ADAPALENE	0.1%	GEL;TOPICAL	Over-the-counter	No	090962	P AND L
ADAPALENE	ADAPALENE	0.1%	GEL;TOPICAL	Over-the-counter	No	215940	TARO
DIFFERIN	ADAPALENE	0.1%	GEL;TOPICAL	Over-the-counter	Yes	020380	GALDERMA LABS LP

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