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FDA NDA · NDA019309

VASOTEC

Sponsor: BIOVAIL LABS INTL

APPLICATION
NDA019309
TYPE
NDA
ORIGINAL APPROVAL
1988-02-09
LATEST ACTION
2002-11-25
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

VASOTEC · ReferenceDiscontinued
ENALAPRILAT 1.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2002-11-25Manufacturing (CMC) · Supplement 27 · standardAP
2002-11-01Labeling · Supplement 25 · standard — Letter ↗AP
2001-12-17Manufacturing (CMC) · Supplement 26 · standardAP
2001-11-27Labeling · Supplement 23 · standard — Review ↗AP
2000-12-06Manufacturing (CMC) · Supplement 24 · standardAP
1999-02-17Labeling · Supplement 22 · standard — Review ↗AP
1997-10-27Labeling · Supplement 20 · standardAP
1997-06-11Labeling · Supplement 21 · standard — Review ↗AP
1996-07-31Labeling · Supplement 12 · standard — Review ↗AP
1995-09-28Labeling · Supplement 19 · standard — Review ↗AP
1994-07-25Labeling · Supplement 18 · standard — Review ↗AP
1994-05-11Labeling · Supplement 15 · standard — Review ↗AP
1994-02-18Labeling · Supplement 17 · standard — Review ↗AP
1994-01-14Labeling · Supplement 14 · standard — Review ↗AP
1993-10-21Labeling · Supplement 16 · standard — Review ↗AP
1993-02-24Labeling · Supplement 13 · standard — Review ↗AP
1992-09-30Labeling · Supplement 11 · standard — Review ↗AP
1992-05-13Labeling · Supplement 10 · standardAP
1992-05-07Labeling · Supplement 9 · standardAP
1992-01-29Labeling · Supplement 7 · standardAP
1991-02-06Labeling · Supplement 8 · standard — Review ↗AP
1990-03-09Labeling · Supplement 6 · standardAP
1989-11-30Labeling · Supplement 5 · standard — Review ↗AP
1989-10-19Labeling · Supplement 4 · standardAP
1989-04-18Labeling · Supplement 3 · standardAP
1989-01-10Labeling · Supplement 1 · standardAP
1988-02-09Type 2 - New Active Ingredient · Original · standard — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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