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Drugs@FDA: FDA-Approved Drugs

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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
06/10/2026	SUPPL-28	Labeling-Package Insert		Label is not available on this site.
04/26/2024	SUPPL-24	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
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
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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