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GATTEX KIT

NDA · New Drug Application · Sponsor: TAKEDA PHARMS USA · Approved 2012-12-21

Drug application

FDA Application #
NDA203441
Application type
New Drug Application
Brand name
GATTEX KIT
Generic name
TEDUGLUTIDE
Active ingredients
TEDUGLUTIDE
Dosage form
POWDER
Route
SUBCUTANEOUS
Marketing status
Prescription
Sponsor
TAKEDA PHARMS USA
Manufacturer
Takeda Pharmaceuticals America, Inc.
First approval
2012-12-21

Source

Authoritative
Drugs@FDA application overview
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