← FDA DRUG APPROVALS

FDA NDA · NDA018240

TENORMIN

atenolol

Sponsor: TWI PHARMS

APPLICATION
NDA018240
TYPE
NDA
ORIGINAL APPROVAL
1981-08-19
LATEST ACTION
2023-12-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

TENORMIN · ReferencePrescription
ATENOLOL 25MG · TABLET · ORAL
TENORMIN · ReferencePrescription
ATENOLOL 100MG · TABLET · ORAL
TENORMIN · ReferencePrescription
ATENOLOL 50MG · TABLET · ORAL

Approval history

2023-12-22Labeling · Supplement 47 · standard — Letter ↗AP
2015-09-10Manufacturing (CMC) · Supplement 39 · standardAP
2015-09-03Manufacturing (CMC) · Supplement 38 · standardAP
2015-08-27Manufacturing (CMC) · Supplement 37 · standardAP
2015-07-16Manufacturing (CMC) · Supplement 35 · standardAP
2015-07-15Manufacturing (CMC) · Supplement 34 · standardAP
2015-07-09Manufacturing (CMC) · Supplement 33 · standardAP
2012-10-31Labeling · Supplement 32 · unknown — Letter ↗AP
2011-08-17Labeling · Supplement 31 · standard — Letter ↗AP
2008-04-29Labeling · Supplement 30 · standard — Letter ↗AP
2005-02-09Labeling · Supplement 29 · standard — Letter ↗AP
2003-11-06Labeling · Supplement 28 · standard — Letter ↗AP
2003-01-09Labeling · Supplement 27 · standard — Letter ↗AP
2000-04-04Labeling · Supplement 25 · standard — Review ↗AP
1999-07-21Labeling · Supplement 26 · standard — Review ↗AP
1996-10-11Manufacturing (CMC) · Supplement 24 · standardAP
1996-02-09Labeling · Supplement 23 · standardAP
1994-05-04Labeling · Supplement 21 · standardAP
1993-04-29Labeling · Supplement 20 · standardAP
1992-08-05Labeling · Supplement 19AP
1992-08-05Labeling · Supplement 18AP
1991-09-18Labeling · Supplement 17AP
1991-02-21Labeling · Supplement 15AP
1991-02-21Labeling · Supplement 16AP
1991-02-21Labeling · Supplement 14AP
1990-04-09Efficacy · Supplement 13AP
1989-09-13Efficacy · Supplement 5AP
1987-02-13Manufacturing (CMC) · Supplement 11 · standardAP
1985-09-18Labeling · Supplement 9AP
1985-09-04Efficacy · Supplement 2AP
1984-11-19Manufacturing (CMC) · Supplement 8 · standardAP
1984-07-12Manufacturing (CMC) · Supplement 7 · standardAP
1983-12-15Manufacturing (CMC) · Supplement 6 · standardAP
1983-09-27Manufacturing (CMC) · Supplement 4 · standardAP
1983-04-07Manufacturing (CMC) · Supplement 3 · standardAP
1981-09-23Labeling · Supplement 1AP
1981-08-19Type 1 - New Molecular Entity · Original · standardAP
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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