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FDA NDA · NDA218527

CHEWTADZY

Sponsor: B BETTER

APPLICATION
NDA218527
TYPE
NDA
ORIGINAL APPROVAL
2024-06-28
LATEST ACTION
2024-06-28
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Discontinued

Products

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TADALAFIL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, CHEWABLE · ORAL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TADALAFIL 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, CHEWABLE · ORAL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TADALAFIL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, CHEWABLE · ORAL

Approval history

2024-06-28Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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