Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089895
Company: BARR

Products on ANDA 089895

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CHLORZOXAZONE	CHLORZOXAZONE	500MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 089895

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/04/1988	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
12/21/1999	SUPPL-16	Manufacturing (CMC)-Facility		Label is not available on this site.
09/07/1999	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
09/07/1999	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
05/20/1999	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
12/01/1998	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
07/06/1998	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
06/20/1997	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
02/05/1996	SUPPL-9	Labeling		Label is not available on this site.
12/23/1994	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
10/17/1994	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
10/11/1994	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
10/05/1993	SUPPL-5	Labeling		Label is not available on this site.
04/03/1992	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
04/03/1992	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
02/06/1991	SUPPL-1	Labeling		Label is not available on this site.