Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065067
Company: FOUGERA PHARMS

Products on ANDA 065067

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065067

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/31/2002	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/065067.pdf

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.
05/13/2003	SUPPL-3	Labeling		Label is not available on this site.
12/16/2002	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 065067

CLINDAMYCIN PHOSPHATE

LOTION;TOPICAL; EQ 1% BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLEOCIN T	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION;TOPICAL	Prescription	Yes	AB	050600	PFIZER
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION;TOPICAL	Prescription	No	AB	215607	ENCUBE
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION;TOPICAL	Prescription	No	AB	065067	FOUGERA PHARMS
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION;TOPICAL	Prescription	No	AB	214604	PADAGIS ISRAEL
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION;TOPICAL	Prescription	No	AB	214526	TARO