Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085961
Company: CLONMEL HLTHCARE

Products on ANDA 085961

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 085961

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/19/1977	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
10/01/1998	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
06/23/1998	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
06/23/1998	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
12/02/1994	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
03/26/1991	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
07/20/1989	SUPPL-18	Bioequivalence		Label is not available on this site.
03/26/1991	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
03/26/1991	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
05/02/1985	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
09/27/1984	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
05/06/1983	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
08/05/1982	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
03/15/1982	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
03/15/1982	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.