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FDA ANDA · ANDA085159

METHOCARBAMOL

Sponsor: HIKMA INTL PHARMS

APPLICATION
ANDA085159
TYPE
ANDA
ORIGINAL APPROVAL
1976-08-11
LATEST ACTION
2015-12-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

METHOCARBAMOLDiscontinued
METHOCARBAMOL 500MG · TABLET · ORAL

Approval history

2015-12-07Labeling · Supplement 51 · standardAP
2002-10-28Manufacturing (CMC) · Supplement 42AP
2002-03-12Manufacturing (CMC) · Supplement 41AP
1999-03-11Manufacturing (CMC) · Supplement 35AP
1999-03-11Manufacturing (CMC) · Supplement 33AP
1999-03-11Labeling · Supplement 38AP
1999-03-11Manufacturing (CMC) · Supplement 36AP
1999-03-11Manufacturing (CMC) · Supplement 34AP
1998-10-01Manufacturing (CMC) · Supplement 39AP
1996-02-22Manufacturing (CMC) · Supplement 31AP
1996-02-22Labeling · Supplement 32AP
1995-01-13Manufacturing (CMC) · Supplement 29AP
1995-01-13Manufacturing (CMC) · Supplement 28AP
1995-01-13Manufacturing (CMC) · Supplement 30AP
1992-12-02Labeling · Supplement 27AP
1990-09-17Manufacturing (CMC) · Supplement 23AP
1989-05-02Labeling · Supplement 19AP
1987-02-04Manufacturing (CMC) · Supplement 20AP
1986-04-09Manufacturing (CMC) · Supplement 15AP
1986-04-09Manufacturing (CMC) · Supplement 16AP
1986-04-09Manufacturing (CMC) · Supplement 14AP
1984-11-20Manufacturing (CMC) · Supplement 13AP
1984-06-27Manufacturing (CMC) · Supplement 12AP
1982-04-21Manufacturing (CMC) · Supplement 5AP
1982-04-01Manufacturing (CMC) · Supplement 3AP
1982-04-01Manufacturing (CMC) · Supplement 4AP
1976-08-11OriginalAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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