← FDA DRUG APPROVALS

FDA NDA · NDA019002

VASCOR

Sponsor: JOHNSON AND JOHNSON

APPLICATION
NDA019002
TYPE
NDA
ORIGINAL APPROVAL
1990-12-28
LATEST ACTION
2001-02-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

VASCORDiscontinued
BEPRIDIL HYDROCHLORIDE 300MG · TABLET · ORAL
VASCORDiscontinued
BEPRIDIL HYDROCHLORIDE 400MG · TABLET · ORAL
VASCORDiscontinued
BEPRIDIL HYDROCHLORIDE 200MG · TABLET · ORAL

Approval history

2001-02-06Manufacturing (CMC) · Supplement 10 · priorityAP
2000-07-12Labeling · Supplement 9 · priorityAP
1998-03-10Labeling · Supplement 7 · priorityAP
1994-06-28Manufacturing (CMC) · Supplement 6 · priorityAP
1994-05-12Manufacturing (CMC) · Supplement 2 · priority — Review ↗AP
1993-10-06Manufacturing (CMC) · Supplement 1 · priorityAP
1993-01-28Manufacturing (CMC) · Supplement 5 · priorityAP
1993-01-28Labeling · Supplement 3 · priorityAP
1993-01-28Labeling · Supplement 4 · priorityAP
1990-12-28Type 1 - New Molecular Entity · Original · priorityAP
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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