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FDA NDA · NDA019058

TENORMIN

Sponsor: ASTRAZENECA

APPLICATION
NDA019058
TYPE
NDA
ORIGINAL APPROVAL
1989-09-13
LATEST ACTION
2005-02-09
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

TENORMIN · ReferenceDiscontinued
ATENOLOL 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2005-02-09Labeling · Supplement 17 · priority — Letter ↗AP
2003-11-06Labeling · Supplement 16 · priority — Letter ↗AP
2003-01-22Labeling · Supplement 15 · priority — Letter ↗AP
2001-10-19Manufacturing (CMC) · Supplement 14 · priorityAP
2000-04-04Labeling · Supplement 12 · priority — Review ↗AP
1999-07-21Labeling · Supplement 13 · priority — Review ↗AP
1998-02-05Manufacturing (CMC) · Supplement 11 · priorityAP
1996-03-20Labeling · Supplement 10 · priorityAP
1994-05-04Labeling · Supplement 8 · priorityAP
1993-04-29Labeling · Supplement 7 · priorityAP
1992-08-05Labeling · Supplement 6 · priorityAP
1992-08-05Labeling · Supplement 5 · priorityAP
1991-09-18Labeling · Supplement 4 · priorityAP
1991-04-17Labeling · Supplement 3 · priorityAP
1991-04-05Labeling · Supplement 2 · priorityAP
1991-04-05Labeling · Supplement 1 · priorityAP
1989-09-13Type 3 - New Dosage Form · Original · priorityAP
VIEW ON DRUGS@FDA ↗

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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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