APPLICATION
ANDA083245
TYPE
ANDA
ORIGINAL APPROVAL
1975-02-13
LATEST ACTION
2019-02-06
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
NEMBUTAL SODIUMDiscontinued
PENTOBARBITAL SODIUM 100MG · CAPSULE · ORAL
Approval history
2019-02-06Labeling · Supplement 14 · standardAP
1998-04-20Manufacturing (CMC) · Supplement 11AP
1992-05-22Labeling · Supplement 9AP
1975-02-13OriginalAP
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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