Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020748
Company: GALDERMA LABS LP

Products on NDA 020748

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIFFERIN	ADAPALENE	0.1%	CREAM;TOPICAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020748

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/26/2000	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20748lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20748ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020748_differin.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/01/2014	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
02/08/2013	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
09/25/2001	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 020748

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/26/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20748lbl.pdf

Therapeutic Equivalents for NDA 020748

DIFFERIN

CREAM;TOPICAL; 0.1%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ADAPALENE	ADAPALENE	0.1%	CREAM;TOPICAL	Prescription	No	AB	090824	FOUGERA PHARMS
DIFFERIN	ADAPALENE	0.1%	CREAM;TOPICAL	Prescription	Yes	AB	020748	GALDERMA LABS LP