APPLICATION
ANDA201947
TYPE
ANDA
ORIGINAL APPROVAL
2012-01-05
LATEST ACTION
2018-09-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
MORPHINE SULFATEDiscontinued
MORPHINE SULFATE 10MG/5ML · SOLUTION · ORAL
MORPHINE SULFATEDiscontinued
MORPHINE SULFATE 20MG/5ML · SOLUTION · ORAL
Approval history
2018-09-18REMS · Supplement 4AP
2012-01-05Not Applicable · OriginalAP
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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