APPLICATION
ANDA202348
TYPE
ANDA
ORIGINAL APPROVAL
2011-07-15
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
MORPHINE SULFATEPrescription
MORPHINE SULFATE 100MG/5ML · SOLUTION · ORAL
Approval history
2026-06-18REMS · Supplement 20AP
2024-10-31REMS · Supplement 16AP
2020-02-24Labeling · Supplement 7 · standardAP
2020-02-24Labeling · Supplement 5 · standardAP
2020-02-24Labeling · Supplement 8 · standardAP
2018-09-18REMS · Supplement 6AP
2016-10-31Labeling · Supplement 3 · standardAP
2015-05-04Labeling · Supplement 1 · standardAP
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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