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FDA ANDA · ANDA206245
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Sponsor: NOVEL LABS INC
APPLICATION
ANDA206245
TYPE
ANDA
ORIGINAL APPROVAL
2016-12-01
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 325MG, HYDROCODONE BITARTRATE 7.5MG · TABLET · ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 325MG, HYDROCODONE BITARTRATE 10MG · TABLET · ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 325MG, HYDROCODONE BITARTRATE 5MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 19AP
2026-01-08Labeling · Supplement 18 · standardAP
2024-10-31REMS · Supplement 17AP
2024-03-18Labeling · Supplement 15 · standardAP
2024-03-18Labeling · Supplement 14 · standardAP
2021-03-04Labeling · Supplement 11 · standardAP
2019-10-11Labeling · Supplement 8 · standardAP
2018-09-20Labeling · Supplement 6 · standardAP
2018-09-18REMS · Supplement 5AP
2017-12-18Manufacturing (CMC) · Supplement 3 · unknownAP
2017-12-18Labeling · Supplement 1 · 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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