APPLICATION
ANDA207595
TYPE
ANDA
ORIGINAL APPROVAL
2019-01-11
LATEST ACTION
2025-12-22
ROUTE
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
NALBUPHINE HYDROCHLORIDEDiscontinued
NALBUPHINE HYDROCHLORIDE 10MG/ML (10MG/ML) · SOLUTION · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
NALBUPHINE HYDROCHLORIDEDiscontinued
NALBUPHINE HYDROCHLORIDE 20MG/ML (20MG/ML) · SOLUTION · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Approval history
2025-12-22Labeling · Supplement 4 · standardAP
2025-11-18Labeling · Supplement 3 · standardAP
2023-12-15Labeling · Supplement 2 · standardAP
2019-10-10Labeling · Supplement 1 · standardAP
2019-01-11UNKNOWN · 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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