APPLICATION
ANDA209036
TYPE
ANDA
ORIGINAL APPROVAL
2017-06-21
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
HYDROCODONE BITARTRATE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 300MG, HYDROCODONE BITARTRATE 7.5MG · TABLET · ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 300MG, HYDROCODONE BITARTRATE 10MG · TABLET · ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 300MG, HYDROCODONE BITARTRATE 5MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 22AP
2025-12-22Labeling · Supplement 21 · standardAP
2025-01-29Labeling · Supplement 17 · standardAP
2024-10-31REMS · Supplement 18AP
2023-12-15Labeling · Supplement 14 · standardAP
2023-12-15Labeling · Supplement 12 · standardAP
2021-03-05Labeling · Supplement 5 · standardAP
2019-10-11Labeling · Supplement 3 · standardAP
2018-09-20Labeling · Supplement 2 · standardAP
2018-09-18REMS · Supplement 1AP
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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