APPLICATION
ANDA075824
TYPE
ANDA
ORIGINAL APPROVAL
2002-03-12
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 23AP
2025-12-22Labeling · Supplement 22 · standardAP
2025-12-22Labeling · Supplement 20 · standardAP
2024-10-31REMS · Supplement 21AP
2023-12-15Labeling · Supplement 19 · standardAP
2021-03-04Labeling · Supplement 14 · standardAP
2019-10-07Labeling · Supplement 13 · standardAP
2018-09-21Labeling · Supplement 12 · standardAP
2018-09-18REMS · Supplement 11AP
2017-03-23Labeling · Supplement 9 · standardAP
2016-12-16Labeling · Supplement 8 · 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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