Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065139
Company: FOUGERA PHARMS

Products on ANDA 065139

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 2% BASE	CREAM;VAGINAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065139

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/27/2004	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/065139ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/08/2023	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
02/08/2023	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
02/08/2023	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
02/08/2023	SUPPL-8	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 065139

CLINDAMYCIN PHOSPHATE

CREAM;VAGINAL; EQ 2% BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLEOCIN	CLINDAMYCIN PHOSPHATE	EQ 2% BASE	CREAM;VAGINAL	Prescription	Yes	AB	050680	PFIZER
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 2% BASE	CREAM;VAGINAL	Prescription	No	AB	065139	FOUGERA PHARMS