← FDA DRUG APPROVALS

FDA NDA · NDA021368

CIALIS

tadalafil

Sponsor: LILLY

APPLICATION
NDA021368
TYPE
NDA
ORIGINAL APPROVAL
2003-11-21
LATEST ACTION
2018-02-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued

Products

CIALIS · ReferencePrescription
TADALAFIL 20MG · TABLET · ORAL
CIALIS · ReferencePrescription
TADALAFIL 5MG · TABLET · ORAL
CIALIS · ReferenceDiscontinued
TADALAFIL 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
CIALIS · ReferencePrescription
TADALAFIL 10MG · TABLET · ORAL

Approval history

2018-02-15Efficacy · Supplement 30 · priority — Label ↗AP
2017-05-05Labeling · Supplement 29 · standard — Label ↗AP
2016-07-12Manufacturing (CMC) · Supplement 28AP
2016-04-22Labeling · Supplement 27 · standard — Letter ↗AP
2015-09-16Labeling · Supplement 26 · standard — Letter ↗AP
2015-09-01Manufacturing (CMC) · Supplement 25AP
2014-04-29Labeling · Supplement 23 · standard — Label ↗AP
2013-10-10Efficacy · Supplement 22 · standard — Letter ↗AP
2011-10-06Efficacy · Supplement 20 · standard — Label ↗AP
2011-10-06Efficacy · Supplement 21 · standard — Label ↗AP
2010-02-01Labeling · Supplement 17 · unknown — Letter ↗AP
2008-08-07Labeling · Supplement 13 · standard — Letter ↗AP
2008-01-07Efficacy · Supplement 11 · unknown — Letter ↗AP
2007-10-18Labeling · Supplement 12 · standard — Letter ↗AP
2007-01-22Labeling · Supplement 7 · standard — Label ↗AP
2006-10-23Labeling · Supplement 10 · standard — Label ↗AP
2006-10-23Labeling · Supplement 9 · standard — Letter ↗AP
2006-03-07Labeling · Supplement 8 · standard — Label ↗AP
2005-07-08Labeling · Supplement 6 · standard — Letter ↗AP
2005-03-31Labeling · Supplement 5 · standard — Label ↗AP
2005-03-31Labeling · Supplement 4 · standard — Letter ↗AP
2003-11-21Type 1 - New Molecular Entity · Original · standard — Label ↗AP
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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