Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085123
Company: HIKMA INTL PHARMS

Products on ANDA 085123

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHOCARBAMOL	METHOCARBAMOL	750MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 085123

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/18/1976	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
05/08/2015	SUPPL-49	Labeling-Package Insert		Label is not available on this site.
10/28/2002	SUPPL-39	Manufacturing (CMC)		Label is not available on this site.
03/12/2002	SUPPL-38	Manufacturing (CMC)-Control		Label is not available on this site.
10/02/2000	SUPPL-37	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
10/01/1998	SUPPL-35	Manufacturing (CMC)		Label is not available on this site.
03/11/1999	SUPPL-34	Labeling		Label is not available on this site.
03/11/1999	SUPPL-32	Manufacturing (CMC)		Label is not available on this site.
03/11/1999	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
03/11/1999	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.
11/08/1995	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
02/22/1996	SUPPL-28	Labeling		Label is not available on this site.
02/22/1996	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
01/13/1995	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
01/13/1995	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
01/13/1995	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
12/17/1992	SUPPL-23	Labeling		Label is not available on this site.
11/21/1990	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
05/02/1989	SUPPL-18	Labeling		Label is not available on this site.
02/04/1987	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
05/02/1989	SUPPL-15	Labeling		Label is not available on this site.
04/09/1986	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
04/09/1986	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
04/09/1986	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
05/19/1982	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
05/19/1982	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
05/19/1982	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
05/19/1982	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.