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FDA ANDA · ANDA206142
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Sponsor: NOVEL LABS INC
APPLICATION
ANDA206142
TYPE
ANDA
ORIGINAL APPROVAL
2016-11-14
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 300MG, HYDROCODONE BITARTRATE 10MG · TABLET · ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 300MG, HYDROCODONE BITARTRATE 5MG · TABLET · ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 300MG, HYDROCODONE BITARTRATE 7.5MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 14AP
2025-12-22Labeling · Supplement 13 · standardAP
2025-12-22Labeling · Supplement 12 · standardAP
2024-10-31REMS · Supplement 11AP
2023-12-15Labeling · Supplement 9 · standardAP
2023-12-15Labeling · Supplement 10 · standardAP
2021-03-04Labeling · Supplement 7 · standardAP
2019-10-11Labeling · Supplement 6 · standardAP
2018-09-20Labeling · Supplement 4 · standardAP
2018-09-18REMS · Supplement 2AP
2018-09-11Labeling · Supplement 3 · standardAP
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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