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FDA ANDA · ANDA085380

BUTISOL SODIUM

Sponsor: MEDA PHARMS

APPLICATION
ANDA085380
TYPE
ANDA
ORIGINAL APPROVAL
1978-04-10
LATEST ACTION
2000-05-03
ROUTE
ORAL
DOSAGE FORM
ELIXIR
MARKETING STATUS
Discontinued

Products

BUTISOL SODIUMDiscontinued
BUTABARBITAL SODIUM 30MG/5ML · ELIXIR · ORAL

Approval history

2000-05-03Manufacturing (CMC) · Supplement 28AP
1999-10-29Manufacturing (CMC) · Supplement 26AP
1999-04-14Labeling · Supplement 24AP
1998-03-13Manufacturing (CMC) · Supplement 23AP
1992-09-18Manufacturing (CMC) · Supplement 22AP
1992-05-13Manufacturing (CMC) · Supplement 20AP
1992-05-13Manufacturing (CMC) · Supplement 21AP
1990-04-03Manufacturing (CMC) · Supplement 18AP
1990-04-03Manufacturing (CMC) · Supplement 19AP
1990-04-03Manufacturing (CMC) · Supplement 17AP
1987-02-10Manufacturing (CMC) · Supplement 16AP
1985-03-21Manufacturing (CMC) · Supplement 12AP
1985-03-21Manufacturing (CMC) · Supplement 13AP
1983-12-08Manufacturing (CMC) · Supplement 11AP
1983-09-07Manufacturing (CMC) · Supplement 10AP
1983-09-07Manufacturing (CMC) · Supplement 8AP
1982-12-07Manufacturing (CMC) · Supplement 5AP
1978-04-10Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

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