APPLICATION
ANDA211484
TYPE
ANDA
ORIGINAL APPROVAL
2018-12-13
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LEVORPHANOL TARTRATEPrescription
LEVORPHANOL TARTRATE 2MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 13AP
2025-12-22Labeling · Supplement 9 · standardAP
2025-12-22Labeling · Supplement 12 · standardAP
2024-10-31REMS · Supplement 11AP
2023-12-15Labeling · Supplement 8 · standardAP
2021-03-04Labeling · Supplement 6 · standardAP
2021-03-01Labeling · Supplement 2 · standardAP
2019-10-11Labeling · 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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