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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 064159
Company: FOUGERA PHARMS INC

Products on ANDA 064159

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 064159

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/05/1997	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/064159.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/22/2025	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
08/22/2025	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
08/22/2025	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
08/22/2025	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
08/22/2025	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
06/02/2005	SUPPL-4	Labeling		Label is not available on this site.
06/16/2004	SUPPL-2	Labeling		Label is not available on this site.
02/26/2001	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 064159

CLINDAMYCIN PHOSPHATE

SOLUTION;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	SOLUTION;TOPICAL	Prescription	No	AT	209846	CHARTWELL RX
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION;TOPICAL	Prescription	No	AT	209914	ENCUBE ETHICALS
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION;TOPICAL	Prescription	No	AT	064159	FOUGERA PHARMS INC
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION;TOPICAL	Prescription	No	AT	064050	PADAGIS US
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION;TOPICAL	Prescription	No	AT	218300	RISING
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION;TOPICAL	Prescription	No	AT	065184	TARO PHARM INDS
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION;TOPICAL	Prescription	No	AT	208767	ZYDUS LIFESCIENCES

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