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): 064050
Company: PADAGIS US

Products on ANDA 064050

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 064050

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/30/1995	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/11/2023	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
05/12/2016	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
05/12/2016	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
05/12/2016	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
04/05/2001	SUPPL-6	Manufacturing (CMC)-Formulation		Label is not available on this site.
11/08/1999	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
05/19/1998	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 064050

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
CLINDA-DERM	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION;TOPICAL	Prescription	No	AT	063329	PADAGIS US
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	065184	TARO PHARM INDS
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION;TOPICAL	Prescription	No	AT	208767	ZYDUS LIFESCIENCES

Top