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FDA ANDA · ANDA087336

LORCET-HD

Sponsor: MALLINCKRODT

APPLICATION
ANDA087336
TYPE
ANDA
ORIGINAL APPROVAL
1982-07-08
LATEST ACTION
2000-07-20
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

LORCET-HDDiscontinued
ACETAMINOPHEN 500MG, HYDROCODONE BITARTRATE 5MG · CAPSULE · ORAL

Approval history

2000-07-20Manufacturing (CMC) · Supplement 27AP
1997-06-05Manufacturing (CMC) · Supplement 25AP
1995-12-18Labeling · Supplement 26AP
1994-09-29Manufacturing (CMC) · Supplement 24AP
1994-08-15Labeling · Supplement 17AP
1993-12-21Manufacturing (CMC) · Supplement 23AP
1991-12-11Manufacturing (CMC) · Supplement 22AP
1991-07-15Manufacturing (CMC) · Supplement 16AP
1989-11-01Labeling · Supplement 21AP
1989-09-22Labeling · Supplement 20AP
1989-09-07Labeling · Supplement 19AP
1989-02-22Manufacturing (CMC) · Supplement 6AP
1989-02-22Manufacturing (CMC) · Supplement 15AP
1989-02-22Manufacturing (CMC) · Supplement 13AP
1988-09-19Labeling · Supplement 18AP
1988-03-08Labeling · Supplement 12AP
1984-12-07Manufacturing (CMC) · Supplement 2AP
1983-12-16Manufacturing (CMC) · Supplement 1AP
1982-07-08OriginalAP
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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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