APPLICATION
ANDA073509
TYPE
ANDA
ORIGINAL APPROVAL
1992-09-30
LATEST ACTION
2020-02-10
ROUTE
EPIDURAL, INTRATHECAL, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
MORPHINE SULFATEPrescription
MORPHINE SULFATE 0.5MG/ML · INJECTABLE · INJECTION
Approval history
2020-02-10Labeling · Supplement 19 · standardAP
2002-10-25Manufacturing (CMC) · Supplement 10AP
2001-03-22Manufacturing (CMC) · Supplement 8AP
2001-03-22Manufacturing (CMC) · Supplement 9AP
2000-01-07Labeling · Supplement 6AP
2000-01-07Manufacturing (CMC) · Supplement 5AP
1999-07-22Manufacturing (CMC) · Supplement 7AP
1996-10-22Manufacturing (CMC) · Supplement 3AP
1996-10-03Manufacturing (CMC) · Supplement 4AP
1995-11-09Manufacturing (CMC) · Supplement 1AP
1992-09-30OriginalAP
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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