Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062811
Company: G AND W LABS INC

Products on ANDA 062811

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION;TOPICAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062811

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/01/1988	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
06/01/2016	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
06/01/2016	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
06/01/2016	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
11/14/2014	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
11/20/2002	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
01/17/2001	SUPPL-9	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/08/2001	SUPPL-8	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/22/2001	SUPPL-7	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/22/2001	SUPPL-6	Manufacturing (CMC)-Facility		Label is not available on this site.
10/03/2000	SUPPL-5	Manufacturing (CMC)-Packaging		Label is not available on this site.
11/12/1997	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
09/23/1996	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
06/23/1994	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.