APPLICATION
ANDA074471
TYPE
ANDA
ORIGINAL APPROVAL
1998-03-19
LATEST ACTION
2025-12-22
ROUTE
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
NALBUPHINE HYDROCHLORIDEDiscontinued
NALBUPHINE HYDROCHLORIDE 100MG/10ML (10MG/ML) · SOLUTION · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
NALBUPHINE HYDROCHLORIDEDiscontinued
NALBUPHINE HYDROCHLORIDE 200MG/10ML (20MG/ML) · SOLUTION · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Approval history
2025-12-22Labeling · Supplement 9 · standardAP
2024-09-26Labeling · Supplement 8 · standardAP
2023-12-15Labeling · Supplement 7 · standardAP
2023-12-15Labeling · Supplement 6 · standardAP
2023-12-01Labeling · Supplement 5 · standardAP
2019-10-09Labeling · Supplement 4 · standardAP
2016-12-16Labeling · Supplement 3 · standardAP
2016-12-16Labeling · Supplement 2 · standardAP
1999-04-23Manufacturing (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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