APPLICATION
ANDA206986
TYPE
ANDA
ORIGINAL APPROVAL
2020-01-21
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
HYDROCODONE BITARTRATEPrescription
HYDROCODONE BITARTRATE 50MG · CAPSULE, EXTENDED RELEASE · ORAL
HYDROCODONE BITARTRATEPrescription
HYDROCODONE BITARTRATE 30MG · CAPSULE, EXTENDED RELEASE · ORAL
HYDROCODONE BITARTRATEPrescription
HYDROCODONE BITARTRATE 15MG · CAPSULE, EXTENDED RELEASE · ORAL
HYDROCODONE BITARTRATEPrescription
HYDROCODONE BITARTRATE 40MG · CAPSULE, EXTENDED RELEASE · ORAL
HYDROCODONE BITARTRATEPrescription
HYDROCODONE BITARTRATE 20MG · CAPSULE, EXTENDED RELEASE · ORAL
HYDROCODONE BITARTRATEPrescription
HYDROCODONE BITARTRATE 10MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2026-06-18REMS · Supplement 10AP
2025-12-22Labeling · Supplement 8 · standardAP
2025-09-26Labeling · Supplement 6 · standardAP
2024-10-31REMS · Supplement 7AP
2023-12-15Labeling · Supplement 5 · standardAP
2023-12-11Labeling · 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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