FDA ANDA · ANDA084292

BUTABARBITAL SODIUM

Sponsor: SANDOZ

APPLICATION

ANDA084292

TYPE

ANDA

LATEST ACTION

1985-08-16

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Discontinued

Products

BUTABARBITAL SODIUMDiscontinued

BUTABARBITAL SODIUM 15MG · TABLET · ORAL

1985-08-16Manufacturing (CMC) · Supplement 65AP

1984-06-05Manufacturing (CMC) · Supplement 62AP

1984-06-05Manufacturing (CMC) · Supplement 63AP

1983-07-21Manufacturing (CMC) · Supplement 60AP

1983-07-21Manufacturing (CMC) · Supplement 61AP

1983-06-03Manufacturing (CMC) · Supplement 57AP

1983-05-16Manufacturing (CMC) · Supplement 59AP

1983-03-30Manufacturing (CMC) · Supplement 55AP

1982-02-09Manufacturing (CMC) · Supplement 51AP

1982-02-09Manufacturing (CMC) · Supplement 52AP

1982-02-09Manufacturing (CMC) · Supplement 50AP

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.

Weekly Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.