APPLICATION
ANDA070918
TYPE
ANDA
ORIGINAL APPROVAL
1989-02-03
LATEST ACTION
2025-12-22
ROUTE
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
NALBUPHINE HYDROCHLORIDEPrescription
NALBUPHINE HYDROCHLORIDE 200MG/10ML (20MG/ML) · SOLUTION · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Approval history
2025-12-22Labeling · Supplement 38 · standardAP
2024-08-27Labeling · Supplement 36 · standardAP
2023-12-15Labeling · Supplement 34 · standardAP
2023-12-01Labeling · Supplement 29 · standardAP
2019-10-16Labeling · Supplement 28 · standardAP
2016-12-16Labeling · Supplement 26 · standardAP
2016-12-16Labeling · Supplement 25 · standardAP
2007-11-30Labeling · Supplement 18AP
2002-10-25Manufacturing (CMC) · Supplement 14AP
1999-07-12Manufacturing (CMC) · Supplement 13AP
1998-05-05Manufacturing (CMC) · Supplement 12AP
1997-02-27Manufacturing (CMC) · Supplement 10AP
1997-02-27Manufacturing (CMC) · Supplement 9AP
1997-02-27Manufacturing (CMC) · Supplement 11AP
1996-10-03Manufacturing (CMC) · Supplement 8AP
1996-04-26Labeling · Supplement 5AP
1991-02-28Labeling · Supplement 3AP
1990-07-25Labeling · Supplement 2AP
1989-02-03OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.