Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085721
Company: WATSON LABS

Products on ANDA 085721

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 085721

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/13/1977	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
04/20/1999	SUPPL-33	Manufacturing (CMC)-Control		Label is not available on this site.
01/21/1999	SUPPL-32	Manufacturing (CMC)		Label is not available on this site.
07/18/1997	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
07/18/1997	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.
07/18/1997	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
04/22/1991	SUPPL-28	Labeling		Label is not available on this site.
02/02/1989	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
02/02/1989	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
04/14/1988	SUPPL-24	Labeling		Label is not available on this site.
12/24/1987	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
07/21/1987	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
07/21/1987	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
12/10/1986	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
01/18/1983	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.