APPLICATION
ANDA083244
TYPE
ANDA
ORIGINAL APPROVAL
1975-01-08
LATEST ACTION
1995-09-20
ROUTE
ORAL
DOSAGE FORM
ELIXIR
MARKETING STATUS
Discontinued
Products
NEMBUTALDiscontinued
PENTOBARBITAL 18.2MG/5ML · ELIXIR · ORAL
Approval history
1995-09-20Labeling · Supplement 10AP
1989-01-31Manufacturing (CMC) · Supplement 9AP
1984-03-30Manufacturing (CMC) · Supplement 6AP
1975-01-08OriginalAP
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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