APPLICATION
ANDA070752
TYPE
ANDA
ORIGINAL APPROVAL
1986-07-02
LATEST ACTION
1991-04-17
ROUTE
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
NALBUPHINEDiscontinued
NALBUPHINE HYDROCHLORIDE 20MG/ML (20MG/ML) · SOLUTION · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
NALBUPHINEDiscontinued
NALBUPHINE HYDROCHLORIDE 200MG/10ML (20MG/ML) · SOLUTION · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Approval history
1991-04-17Labeling · Supplement 9AP
1991-03-27Labeling · Supplement 8AP
1991-02-20Labeling · Supplement 7AP
1990-01-09Labeling · Supplement 6AP
1990-01-09Labeling · Supplement 5AP
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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