APPLICATION
ANDA202310
TYPE
ANDA
ORIGINAL APPROVAL
2015-10-30
LATEST ACTION
2020-02-10
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
MORPHINE SULFATEDiscontinued
MORPHINE SULFATE 20MG/5ML · SOLUTION · ORAL
Approval history
2020-02-10Labeling · Supplement 3 · standardAP
2020-02-10Labeling · Supplement 1 · standardAP
2018-09-18REMS · Supplement 2 · 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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