Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090824
Company: FOUGERA PHARMS

Products on ANDA 090824

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ADAPALENE	ADAPALENE	0.1%	CREAM;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090824

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/30/2010	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090824s000ltr.pdf

Therapeutic Equivalents for ANDA 090824

ADAPALENE

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