APPLICATION
ANDA205479
TYPE
ANDA
ORIGINAL APPROVAL
2021-05-28
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
HYDROCODONE BITARTRATE AND ASPIRINPrescription
ASPIRIN 500MG, HYDROCODONE BITARTRATE 5MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 8AP
2026-01-02Labeling · Supplement 6 · standardAP
2024-11-22Labeling · Supplement 5 · standardAP
2024-10-31REMS · Supplement 4AP
2024-10-03Labeling · Supplement 3 · standardAP
2024-01-03Labeling · Supplement 2 · standardAP
2024-01-03Labeling · 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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