Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 083308
Company: WATSON LABS

Products on ANDA 083308

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MEPROBAMATE	MEPROBAMATE	400MG	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 083308

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/03/1973	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
10/13/1988	SUPPL-66	Labeling		Label is not available on this site.
11/22/2004	SUPPL-51	Labeling		Label is not available on this site.
04/25/2001	SUPPL-49	Manufacturing (CMC)-Control		Label is not available on this site.
01/20/1998	SUPPL-47	Manufacturing (CMC)		Label is not available on this site.
01/20/1998	SUPPL-46	Manufacturing (CMC)		Label is not available on this site.
01/28/1991	SUPPL-44	Manufacturing (CMC)		Label is not available on this site.
08/07/1991	SUPPL-43	Manufacturing (CMC)		Label is not available on this site.
06/29/1990	SUPPL-42	Manufacturing (CMC)		Label is not available on this site.
02/08/1989	SUPPL-41	Labeling		Label is not available on this site.
10/13/1988	SUPPL-40	Labeling		Label is not available on this site.
10/21/1988	SUPPL-39	Manufacturing (CMC)		Label is not available on this site.
10/21/1988	SUPPL-38	Manufacturing (CMC)		Label is not available on this site.
06/02/1982	SUPPL-36	Manufacturing (CMC)		Label is not available on this site.
06/02/1982	SUPPL-35	Manufacturing (CMC)		Label is not available on this site.