An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/22/2025	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
08/22/2025	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
08/22/2025	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
08/22/2025	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
08/22/2025	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
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	218942	AUROBINDO PHARMA LTD
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	SUN PHARMA CANADA
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL;TOPICAL	Prescription	No	AB1	216587	ZYDUS LIFESCIENCES

Top