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Details for New Drug Application (NDA): 203441

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NDA 203441 describes GATTEX KIT, which is a drug marketed by Nps Pharms Inc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the GATTEX KIT profile page.

The generic ingredient in GATTEX KIT is teduglutide recombinant. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the teduglutide recombinant profile page.

Summary for NDA: 203441

Tradename:
GATTEX KIT
Applicant:
Nps Pharms Inc
Ingredient:
teduglutide recombinant
Patents:4
Formulation / Manufacturing:see details

Pharmacology for NDA: 203441

Suppliers and Packaging for NDA: 203441

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GATTEX KIT
teduglutide recombinant
POWDER;SUBCUTANEOUS 203441 NDA Shire-NPS Pharmaceuticals, Inc. 68875-0101 68875-0101-2 30 VIAL in 1 CARTON (68875-0101-2) > .5 mL in 1 VIAL (68875-0101-1)
GATTEX KIT
teduglutide recombinant
POWDER;SUBCUTANEOUS 203441 NDA Shire-NPS Pharmaceuticals, Inc. 68875-0102 68875-0102-1 1 KIT in 1 CARTON (68875-0102-1) * .5 mL in 1 SYRINGE, PLASTIC * .7 mL in 1 PACKET * .5 mL in 1 VIAL (68875-0101-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;SUBCUTANEOUSStrength5MG/VIAL
Approval Date:Dec 21, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 21, 2017
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Dec 21, 2019
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Patent:5,789,379Patent Expiration:Apr 14, 2020Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT


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