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FDA ANDA · ANDA206718

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Sponsor: SPECGX LLC

APPLICATION
ANDA206718
TYPE
ANDA
ORIGINAL APPROVAL
2017-03-31
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

HYDROCODONE BITARTRATE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 300MG, HYDROCODONE BITARTRATE 10MG · TABLET · ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 300MG, HYDROCODONE BITARTRATE 5MG · TABLET · ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 300MG, HYDROCODONE BITARTRATE 7.5MG · TABLET · ORAL

Approval history

2026-06-18REMS · Supplement 19AP
2025-12-22Labeling · Supplement 18 · standardAP
2025-04-03Labeling · Supplement 16 · standardAP
2024-10-31REMS · Supplement 17AP
2024-01-03Labeling · Supplement 15 · standardAP
2024-01-03Labeling · Supplement 13 · standardAP
2021-03-04Labeling · Supplement 10 · standardAP
2019-10-11Labeling · Supplement 7 · standardAP
2018-09-20Labeling · Supplement 6 · standardAP
2018-09-18REMS · Supplement 5AP
2017-03-31UNKNOWN · Original · standard — REMS ↗AP
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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