Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065513
Company: EPIC PHARMA LLC

Products on ANDA 065513

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB;TOPICAL	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065513

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/17/2010	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/22/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 065513

CLINDAMYCIN PHOSPHATE

SWAB;TOPICAL; EQ 1% BASE
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB;TOPICAL	Prescription	No	AT	065513	EPIC PHARMA LLC
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB;TOPICAL	Prescription	No	AT	065049	PADAGIS US
CLINDETS	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB;TOPICAL	Prescription	No	AT	064136	PADAGIS US