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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065049
Company: PADAGIS US

Products on ANDA 065049

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065049

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/25/2000	ORIG-1	Approval			Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65049ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/065049_clindamycin_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/03/2020	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
04/03/2020	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
07/15/2015	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
01/14/2014	SUPPL-11	Labeling-Container/Carton Labels		Label is not available on this site.
10/19/2010	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
11/30/2009	SUPPL-9	Labeling		Label is not available on this site.
06/27/2002	SUPPL-5	Labeling		Label is not available on this site.
06/27/2002	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
11/21/2001	SUPPL-3	Labeling		Label is not available on this site.
11/21/2001	SUPPL-2	Manufacturing (CMC)-Facility		Label is not available on this site.
11/21/2001	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.

Therapeutic Equivalents for ANDA 065049

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

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