APPLICATION
ANDA085383
TYPE
ANDA
ORIGINAL APPROVAL
1979-02-26
LATEST ACTION
1992-03-06
ROUTE
ORAL
DOSAGE FORM
ELIXIR
MARKETING STATUS
Discontinued
Products
BUTABARBITAL SODIUMDiscontinued
BUTABARBITAL SODIUM 30MG/5ML · ELIXIR · ORAL
Approval history
1992-03-06Labeling · Supplement 20AP
1989-12-06Labeling · Supplement 19AP
1989-10-10Labeling · Supplement 18AP
1987-08-20Manufacturing (CMC) · Supplement 15AP
1987-02-26Manufacturing (CMC) · Supplement 13AP
1987-02-26Manufacturing (CMC) · Supplement 14AP
1983-12-08Manufacturing (CMC) · Supplement 8AP
1982-07-29Manufacturing (CMC) · Supplement 6AP
1979-02-26OriginalAP
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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