← FDA DRUG APPROVALS

FDA NDA · NDA022332

ADCIRCA

tadalafil

Sponsor: ELI LILLY CO

APPLICATION
NDA022332
TYPE
NDA
ORIGINAL APPROVAL
2009-05-22
LATEST ACTION
2020-09-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ADCIRCA · ReferencePrescription
TADALAFIL 20MG · TABLET · ORAL

Approval history

2020-09-15Labeling · Supplement 11 · standard — Letter ↗AP
2017-05-05Labeling · Supplement 9 · standard — Letter ↗AP
2015-04-02Labeling · Supplement 7 · standard — Letter ↗AP
2014-04-29Labeling · Supplement 6 · standard — Label ↗AP
2013-11-20Labeling · Supplement 5 · standard — Label ↗AP
2011-02-08Labeling · Supplement 3 · unknown — Label ↗AP
2009-05-22Type 6 - New Indication (no longer used) · Original · standard — Letter ↗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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