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MYTESI

NDA · New Drug Application · Sponsor: NAPO PHARMS INC · Approved 2012-12-31

Drug application

FDA Application #

NDA202292

Application type

New Drug Application

Brand name

MYTESI

Generic name

CROFELEMER

Active ingredients

CROFELEMER

Dosage form

TABLET, DELAYED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

NAPO PHARMS INC

Manufacturer

Napo Pharmaceuticals, Inc.

First approval

2012-12-31

Source

Authoritative

Drugs@FDA application overview

Machine

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