Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 064136
Company: PADAGIS US

Products on ANDA 064136

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 064136

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/30/1996	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
12/09/2003	SUPPL-8	Labeling		Label is not available on this site.
11/01/2002	SUPPL-5	Labeling		Label is not available on this site.
10/17/2002	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
06/29/2001	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
10/22/1999	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
07/29/1997	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 064136

CLINDETS

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