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FDA ANDA · ANDA040846

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Sponsor: MIKART

APPLICATION
ANDA040846
TYPE
ANDA
ORIGINAL APPROVAL
2010-06-09
LATEST ACTION
2021-03-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 325MG, HYDROCODONE BITARTRATE 2.5MG · TABLET · ORAL

Approval history

2021-03-05Labeling · Supplement 15 · standardAP
2019-10-28Labeling · Supplement 14 · standardAP
2018-09-21Labeling · Supplement 12 · standardAP
2018-09-18REMS · Supplement 11AP
2018-08-24Labeling · Supplement 10 · standardAP
2016-12-16Labeling · Supplement 8 · standardAP
2016-12-16Labeling · Supplement 9 · standardAP
2016-12-15Labeling · Supplement 6 · standardAP
2014-05-12Manufacturing (CMC) · Supplement 4 · unknownAP
2013-10-18Labeling · Supplement 5 · standard — Label ↗AP
2011-06-24Labeling · Supplement 3AP
2010-08-25Labeling · Supplement 1AP
2010-06-09OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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