APPLICATION
ANDA074598
TYPE
ANDA
ORIGINAL APPROVAL
1997-06-19
LATEST ACTION
2007-08-29
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
HYDROMORPHONE HYDROCHLORIDEDiscontinued
HYDROMORPHONE HYDROCHLORIDE 10MG/ML · INJECTABLE · INJECTION
Approval history
2007-08-29Labeling · Supplement 11AP
2003-05-14Labeling · Supplement 2AP
2002-12-03Manufacturing (CMC) · Supplement 7AP
2001-03-22Manufacturing (CMC) · Supplement 5AP
2001-03-22Manufacturing (CMC) · Supplement 6AP
2000-06-29Manufacturing (CMC) · Supplement 3AP
2000-06-29Manufacturing (CMC) · Supplement 1AP
2000-06-29Manufacturing (CMC) · Supplement 4AP
1997-06-19OriginalAP
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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