APPLICATION
ANDA075499
TYPE
ANDA
ORIGINAL APPROVAL
2002-12-04
LATEST ACTION
2026-06-18
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Prescription
Products
BUTORPHANOL TARTRATEPrescription
BUTORPHANOL TARTRATE 1MG/SPRAY · SPRAY, METERED · NASAL
Approval history
2026-06-18REMS · Supplement 39AP
2025-12-22Labeling · Supplement 38 · standardAP
2025-12-22Labeling · Supplement 35 · standardAP
2024-10-31REMS · Supplement 36AP
2023-12-15Labeling · Supplement 34 · standardAP
2023-12-15Labeling · Supplement 33 · standardAP
2021-03-05Labeling · Supplement 28 · standardAP
2019-10-09Labeling · Supplement 26 · standardAP
2018-09-20Labeling · Supplement 25 · standardAP
2018-09-18REMS · Supplement 24AP
2017-03-23Labeling · Supplement 22 · standardAP
2016-12-16Labeling · Supplement 18 · standardAP
2016-12-16Labeling · Supplement 20 · standardAP
2009-05-06Labeling · Supplement 11AP
2007-03-19Labeling · Supplement 7AP
2004-04-28Labeling · Supplement 2AP
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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