APPLICATION
ANDA070914
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 10MG/ML (10MG/ML) · SOLUTION · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Approval history
2025-12-22Labeling · Supplement 28 · standardAP
2024-08-27Labeling · Supplement 26 · standardAP
2023-12-15Labeling · Supplement 24 · standardAP
2023-12-01Labeling · Supplement 21 · standardAP
2019-10-16Labeling · Supplement 20 · standardAP
2016-12-16Labeling · Supplement 18 · standardAP
2016-12-16Labeling · Supplement 19 · standardAP
2007-11-30Labeling · Supplement 12AP
1999-07-12Manufacturing (CMC) · Supplement 10AP
1997-02-27Manufacturing (CMC) · Supplement 8AP
1997-02-27Manufacturing (CMC) · Supplement 9AP
1996-10-03Manufacturing (CMC) · Supplement 7AP
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.
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