APPLICATION
ANDA083261
TYPE
ANDA
ORIGINAL APPROVAL
1973-12-19
LATEST ACTION
1993-07-30
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
SODIUM PENTOBARBITALDiscontinued
PENTOBARBITAL SODIUM 50MG/ML · INJECTABLE · INJECTION
Approval history
1993-07-30Manufacturing (CMC) · Supplement 11AP
1993-07-30Manufacturing (CMC) · Supplement 10AP
1989-11-15Labeling · Supplement 9AP
1987-04-28Manufacturing (CMC) · Supplement 7AP
1983-08-12Manufacturing (CMC) · Supplement 5AP
1983-08-12Manufacturing (CMC) · Supplement 4AP
1973-12-19OriginalAP
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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