APPLICATION
ANDA074278
TYPE
ANDA
ORIGINAL APPROVAL
2000-03-31
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription
Products
LEVORPHANOL TARTRATEDiscontinued
LEVORPHANOL TARTRATE 1MG · TABLET · ORAL
LEVORPHANOL TARTRATEDiscontinued
LEVORPHANOL TARTRATE 3MG · TABLET · ORAL
LEVORPHANOL TARTRATEPrescription
LEVORPHANOL TARTRATE 2MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 27AP
2025-12-22Labeling · Supplement 21 · standardAP
2025-12-22Labeling · Supplement 24 · standardAP
2024-10-31REMS · Supplement 22AP
2023-12-15Labeling · Supplement 20 · standardAP
2021-03-04Labeling · Supplement 17 · standardAP
2020-03-05Labeling · Supplement 16 · standardAP
2019-10-11Labeling · Supplement 14 · standardAP
2018-09-21Labeling · Supplement 13 · standardAP
2018-09-18REMS · Supplement 12AP
2016-12-16Labeling · Supplement 8 · standardAP
2016-12-16Labeling · Supplement 9 · standardAP
2008-07-16Labeling · Supplement 5AP
2005-04-08Labeling · Supplement 3AP
2000-09-05Manufacturing (CMC) · 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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