← FDA DRUG APPROVALS

FDA ANDA · ANDA083900

BENZEDRINE

Sponsor: SMITH KLINE & FRENCH

APPLICATION
ANDA083900
TYPE
ANDA
ORIGINAL APPROVAL
1976-02-26
LATEST ACTION
1982-05-11
ROUTE
Oral
DOSAGE FORM
Tablet
MARKETING STATUS
Discontinued

Products

BENZEDRINEDiscontinued
AMPHETAMINE SULFATE 5MG · Tablet · Oral
BENZEDRINEDiscontinued
AMPHETAMINE SULFATE 10MG · Tablet · Oral

Approval history

1982-05-11Manufacturing (CMC) · Supplement 7 — Review ↗AP
1981-02-11Supplement · Supplement 5 — Review ↗AP
1981-02-11Supplement · Supplement 9 — Review ↗AP
1979-12-14Supplement · Supplement 8 — Review ↗AP
1979-02-06Supplement · Supplement 6 — Review ↗AP
1978-11-21Supplement · Supplement 3 — Review ↗AP
1978-11-21Supplement · Supplement 4 — Review ↗AP
1977-05-11Supplement · Supplement 2 — Review ↗AP
1976-04-15Supplement · Supplement 1 — Review ↗AP
1976-02-26Original — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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