APPLICATION
ANDA075759
TYPE
ANDA
ORIGINAL APPROVAL
2001-08-08
LATEST ACTION
2026-06-18
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Discontinued
Products
BUTORPHANOL TARTRATEDiscontinued
BUTORPHANOL TARTRATE 1MG/SPRAY · SPRAY, METERED · NASAL
Approval history
2026-06-18REMS · Supplement 39AP
2025-12-22Labeling · Supplement 38 · standardAP
2024-10-31REMS · Supplement 37AP
2024-10-03Labeling · Supplement 36 · standardAP
2023-12-15Labeling · Supplement 35 · standardAP
2023-12-15Labeling · Supplement 34 · standardAP
2021-03-04Labeling · Supplement 32 · standardAP
2019-10-08Labeling · Supplement 31 · standardAP
2018-09-21Labeling · Supplement 29 · standardAP
2018-09-18REMS · Supplement 28AP
2017-03-07Labeling · Supplement 25 · standardAP
2016-12-16Labeling · Supplement 24 · standardAP
2016-12-16Labeling · Supplement 22 · standardAP
2002-10-17Labeling · Supplement 5AP
2002-08-26Manufacturing (CMC) · Supplement 2AP
2002-08-26Manufacturing (CMC) · Supplement 3AP
2002-08-26Manufacturing (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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