APPLICATION
ANDA070751
TYPE
ANDA
ORIGINAL APPROVAL
1986-07-02
LATEST ACTION
1991-02-20
ROUTE
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
NALBUPHINEDiscontinued
NALBUPHINE HYDROCHLORIDE 10MG/ML (10MG/ML) · SOLUTION · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
NALBUPHINE HYDROCHLORIDEDiscontinued
NALBUPHINE HYDROCHLORIDE 100MG/10ML (10MG/ML) · SOLUTION · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Approval history
1991-02-20Labeling · Supplement 10AP
1990-01-09Labeling · Supplement 9AP
1989-10-12Labeling · Supplement 8AP
1986-07-02OriginalAP
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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