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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020715

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NDA 020715 describes TRELSTAR, which is a drug marketed by Allergan Sales Llc and is included in three NDAs. It is available from two suppliers. Additional details are available on the TRELSTAR profile page.

The generic ingredient in TRELSTAR is triptorelin pamoate. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the triptorelin pamoate profile page.

Summary for 020715

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Hormonal Agents, Suppressant (Pituitary)

Pharmacology for NDA: 020715

Medical Subject Heading (MeSH) Categories for 020715

Suppliers and Packaging for NDA: 020715

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRELSTAR triptorelin pamoate INJECTABLE;INTRAMUSCULAR 020715 NDA Allergan, Inc. 0023-5902 0023-5902-04 1 KIT in 1 CARTON (0023-5902-04) * 2 mL in 1 VIAL, SINGLE-DOSE * 2 mL in 1 SYRINGE
TRELSTAR triptorelin pamoate INJECTABLE;INTRAMUSCULAR 020715 NDA Actavis Pharma, Inc. 52544-153 52544-153-02 2 mL in 1 VIAL, SINGLE-DOSE (52544-153-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULARStrengthEQ 3.75MG BASE/VIAL
Approval Date:Jun 15, 2000TE:RLD:Yes

Expired Orange Book Patents for NDA: 020715

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan Sales LlcTRELSTARtriptorelin pamoateINJECTABLE;INTRAMUSCULAR020715-001Jun 15, 2000► Subscribe► Subscribe
Allergan Sales LlcTRELSTARtriptorelin pamoateINJECTABLE;INTRAMUSCULAR020715-001Jun 15, 2000► Subscribe► Subscribe
Allergan Sales LlcTRELSTARtriptorelin pamoateINJECTABLE;INTRAMUSCULAR020715-001Jun 15, 2000► Subscribe► Subscribe
Allergan Sales LlcTRELSTARtriptorelin pamoateINJECTABLE;INTRAMUSCULAR020715-001Jun 15, 2000► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Express Scripts
Dow
Mallinckrodt
AstraZeneca
McKesson
Daiichi Sankyo
UBS
Julphar
Moodys
US Army

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