APPLICATION
NDA018024
TYPE
NDA
ORIGINAL APPROVAL
1979-05-15
LATEST ACTION
2025-12-22
ROUTE
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
NUBAIN · ReferenceDiscontinued
NALBUPHINE HYDROCHLORIDE 200MG/10ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
NUBAIN · ReferenceDiscontinued
NALBUPHINE HYDROCHLORIDE 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
NUBAIN · ReferenceDiscontinued
NALBUPHINE HYDROCHLORIDE 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
NUBAIN · ReferenceDiscontinued
NALBUPHINE HYDROCHLORIDE 20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
NUBAIN · ReferenceDiscontinued
NALBUPHINE HYDROCHLORIDE 20MG/ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Approval history
2002-10-25Manufacturing (CMC) · Supplement 39 · standardAP
2002-04-16Manufacturing (CMC) · Supplement 37 · standardAP
2002-01-15Manufacturing (CMC) · Supplement 38 · standardAP
1995-12-15Manufacturing (CMC) · Supplement 35 · standardAP
1994-11-02Labeling · Supplement 32AP
1993-10-15Manufacturing (CMC) · Supplement 33 · standardAP
1990-10-19Manufacturing (CMC) · Supplement 31 · standardAP
1988-11-10Manufacturing (CMC) · Supplement 29 · standardAP
1988-11-10Labeling · Supplement 27AP
1988-03-03Manufacturing (CMC) · Supplement 24 · standardAP
1987-12-07Manufacturing (CMC) · Supplement 28 · standardAP
1987-08-04Labeling · Supplement 26AP
1986-10-23Efficacy · Supplement 16AP
1984-11-28Manufacturing (CMC) · Supplement 23 · standardAP
1984-09-17Manufacturing (CMC) · Supplement 20 · standardAP
1984-09-13Manufacturing (CMC) · Supplement 22 · standardAP
1984-09-13Manufacturing (CMC) · Supplement 21 · standardAP
1984-03-02Manufacturing (CMC) · Supplement 14 · standardAP
1984-03-02Manufacturing (CMC) · Supplement 15 · standardAP
1983-08-17Manufacturing (CMC) · Supplement 19 · standardAP
1983-08-17Manufacturing (CMC) · Supplement 18 · standardAP
1983-02-16Labeling · Supplement 17AP
1982-05-27Manufacturing (CMC) · Supplement 10 · standardAP
1982-05-27Manufacturing (CMC) · Supplement 11 · standardAP
1982-05-20Manufacturing (CMC) · Supplement 12 · standardAP
1982-05-20Manufacturing (CMC) · Supplement 13 · standardAP
1981-04-01Manufacturing (CMC) · Supplement 7 · standardAP
1981-02-20Manufacturing (CMC) · Supplement 6 · standardAP
1980-02-21Manufacturing (CMC) · Supplement 3 · standardAP
1980-01-24Manufacturing (CMC) · Supplement 2 · standardAP
1979-06-28Labeling · Supplement 1AP
1979-05-15Type 1 - New Molecular Entity · Original · 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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