← FDA DRUG APPROVALS

FDA NDA · NDA202292

MYTESI

crofelemer

Sponsor: NAPO PHARMS INC

APPLICATION
NDA202292
TYPE
NDA
ORIGINAL APPROVAL
2012-12-31
LATEST ACTION
2024-04-03
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription

Products

MYTESI · ReferencePrescription
CROFELEMER 125MG · TABLET, DELAYED RELEASE · ORAL

Approval history

2024-04-03Labeling · Supplement 9 · standard — Letter ↗AP
2020-11-16Labeling · Supplement 7 · standard — Label ↗AP
2018-03-06Labeling · Supplement 6 · standard — Label ↗AP
2014-08-20Manufacturing (CMC) · Supplement 2 · priorityAP
2013-11-06Manufacturing (CMC) · Supplement 1 · priorityAP
2012-12-31Type 1 - New Molecular Entity · Original · priority — Review ↗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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