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Generated: November 13, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208956

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NDA 208956 describes TRIPTODUR KIT, which is a drug marketed by Arbor Pharms Llc and is included in one NDA. It is available from one supplier. Additional details are available on the TRIPTODUR KIT profile page.

The generic ingredient in TRIPTODUR KIT is triptorelin pamoate. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the triptorelin pamoate profile page.
Summary for 208956
Tradename:TRIPTODUR KIT
Applicant:Arbor Pharms Llc
Ingredient:triptorelin pamoate
Patents:0
Medical Subject Heading (MeSH) Categories for 208956
Suppliers and Packaging for NDA: 208956
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRIPTODUR KIT triptorelin pamoate FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 208956 NDA Arbor Pharmaceuticals, LLC 24338-150 24338-150-20 1 KIT in 1 CARTON (24338-150-20) * 2 mL in 1 VIAL * 2 mL in 1 SYRINGE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULARStrengthEQ 22.5MG BASE/VIAL
Approval Date:Jun 29, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 29, 2020
Regulatory Exclusivity Use:NEW PRODUCT
Regulatory Exclusivity Expiration:Jun 29, 2024
Regulatory Exclusivity Use:TREATMENT OF PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH CENTRAL PRECOCIOUS PUBERTY

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