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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 064160
Company: FOUGERA PHARMS

Products on ANDA 064160

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL;TOPICAL	Prescription	AB1	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 064160

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/28/2000	ORIG-1	Approval			Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/64160ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/064160_Clindamycin_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/02/2005	SUPPL-8	Labeling		Label is not available on this site.
06/16/2004	SUPPL-6	Labeling		Label is not available on this site.
03/31/2003	SUPPL-5	Labeling		Label is not available on this site.
12/16/2002	SUPPL-2	Labeling		Label is not available on this site.
07/27/2001	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 064160

CLINDAMYCIN PHOSPHATE

GEL;TOPICAL; EQ 1% BASE
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLEOCIN T	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL;TOPICAL	Prescription	Yes	AB1	050615	PFIZER
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL;TOPICAL	Prescription	No	AB1	212466	ALEMBIC
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL;TOPICAL	Prescription	No	AB1	212438	ENCUBE
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL;TOPICAL	Prescription	No	AB1	064160	FOUGERA PHARMS
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL;TOPICAL	Prescription	No	AB1	214251	GLENMARK PHARMS LTD
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL;TOPICAL	Prescription	No	AB1	212104	PADAGIS ISRAEL
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL;TOPICAL	Prescription	No	AB1	211872	SOLARIS PHARMA CORP
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL;TOPICAL	Prescription	No	AB1	214052	TARO
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL;TOPICAL	Prescription	No	AB1	216587	ZYDUS LIFESCIENCES

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