Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 063083
Company: WATSON LABS

Products on ANDA 063083

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE;ORAL	Discontinued	None	No	No
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 063083

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/31/1991	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
11/12/2014	SUPPL-47	Manufacturing (CMC)		Label is not available on this site.
01/18/2013	SUPPL-46	Labeling-Package Insert		Label is not available on this site.
03/09/2005	SUPPL-27	Labeling		Label is not available on this site.
03/15/2004	SUPPL-22	Labeling		Label is not available on this site.
03/18/2003	SUPPL-19	Labeling		Label is not available on this site.
03/18/2003	SUPPL-15	Manufacturing (CMC)-New Strength		Label is not available on this site.
02/19/2002	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
06/29/2001	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
04/25/2001	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
05/01/2001	SUPPL-11	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
05/01/2001	SUPPL-10	Manufacturing (CMC)-Facility		Label is not available on this site.
10/06/1999	SUPPL-9	Labeling		Label is not available on this site.
11/29/1999	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
09/18/1998	SUPPL-6	Labeling		Label is not available on this site.
12/09/1998	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
11/12/1997	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
09/09/1997	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
09/23/1996	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
09/24/1993	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.