APPLICATION
ANDA074317
TYPE
ANDA
ORIGINAL APPROVAL
1995-08-23
LATEST ACTION
1999-05-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
HYDROMORPHONE HYDROCHLORIDEDiscontinued
HYDROMORPHONE HYDROCHLORIDE 10MG/ML · INJECTABLE · INJECTION
Approval history
1999-05-11Manufacturing (CMC) · Supplement 6AP
1999-02-19Manufacturing (CMC) · Supplement 5AP
1999-02-02Manufacturing (CMC) · Supplement 3AP
1997-05-06Manufacturing (CMC) · Supplement 2AP
1996-12-04Manufacturing (CMC) · Supplement 1AP
1995-08-23OriginalAP
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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