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FDA ANDA · ANDA040148

NORCO

Sponsor: APIL

APPLICATION
ANDA040148
TYPE
ANDA
ORIGINAL APPROVAL
1997-02-14
LATEST ACTION
2021-03-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

NORCODiscontinued
ACETAMINOPHEN 325MG, HYDROCODONE BITARTRATE 5MG · TABLET · ORAL
NORCODiscontinued
ACETAMINOPHEN 325MG, HYDROCODONE BITARTRATE 7.5MG · TABLET · ORAL
NORCODiscontinued
ACETAMINOPHEN 325MG, HYDROCODONE BITARTRATE 10MG · TABLET · ORAL
NORCODiscontinued
ACETAMINOPHEN 325MG, HYDROCODONE BITARTRATE 2.5MG · TABLET · ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 500MG, HYDROCODONE BITARTRATE 10MG · TABLET · ORAL

Approval history

2021-03-22Labeling · Supplement 75 · standardAP
2019-10-07Labeling · Supplement 73 · standard — Label ↗AP
2018-09-20Labeling · Supplement 72 · standardAP
2018-09-18REMS · Supplement 71AP
2017-04-07Manufacturing (CMC) · Supplement 51 · unknownAP
2017-02-06Labeling · Supplement 68 · standardAP
2016-12-16Labeling · Supplement 62 · standardAP
2016-12-16Labeling · Supplement 67 · standardAP
2016-12-15Labeling · Supplement 60 · standardAP
2014-12-19Labeling · Supplement 53 · standard — Letter ↗AP
2013-10-18Labeling · Supplement 50 · standardAP
2011-07-01Labeling · Supplement 46AP
2008-01-09Manufacturing (CMC) · Supplement 32AP
2003-07-30Labeling · Supplement 14AP
2003-07-30Labeling · Supplement 15AP
2002-05-21Manufacturing (CMC) · Supplement 13AP
2000-09-12Manufacturing (CMC) · Supplement 4 — Review ↗AP
2000-09-12Manufacturing (CMC) · Supplement 11 — Review ↗AP
2000-09-12Manufacturing (CMC) · Supplement 2 — Review ↗AP
2000-09-12Labeling · Supplement 5 — Review ↗AP
2000-09-12Manufacturing (CMC) · Supplement 3 — Review ↗AP
2000-05-11Labeling · Supplement 12AP
1998-10-29Manufacturing (CMC) · Supplement 6AP
1998-10-07Manufacturing (CMC) · Supplement 1AP
1997-02-14OriginalAP
VIEW ON DRUGS@FDA ↗

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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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