APPLICATION
ANDA085873
TYPE
ANDA
ORIGINAL APPROVAL
1978-05-17
LATEST ACTION
1991-04-29
ROUTE
ORAL
DOSAGE FORM
ELIXIR
MARKETING STATUS
Discontinued
Products
BUTABARBDiscontinued
BUTABARBITAL SODIUM 30MG/5ML · ELIXIR · ORAL
Approval history
1991-04-29Labeling · Supplement 54AP
1990-05-07Labeling · Supplement 49AP
1990-01-22Labeling · Supplement 48AP
1989-02-08Labeling · Supplement 41AP
1988-11-22Labeling · Supplement 42AP
1988-11-22Labeling · Supplement 43AP
1978-05-17OriginalAP
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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