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Details for New Drug Application (NDA): 022437

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NDA 022437 describes TRELSTAR, which is a drug marketed by Allergan Sales Llc and is included in three NDAs. It is available from one supplier. There is one patent protecting this drug. 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. One supplier is listed for this compound. Additional details are available on the triptorelin pamoate profile page.

Summary for NDA: 022437

Tradename:
TRELSTAR
Applicant:
Allergan Sales Llc
Ingredient:
triptorelin pamoate
Patents:1
Therapeutic Class:Hormonal Agents, Suppressant (Pituitary)

Pharmacology for NDA: 022437

Suppliers and Packaging for NDA: 022437

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRELSTAR
triptorelin pamoate
INJECTABLE;INTRAMUSCULAR 022437 NDA Actavis Pharma, Inc. 52544-092 52544-092-76 1 KIT in 1 CARTON (52544-092-76) * 2 mL in 1 VIAL, SINGLE-DOSE (52544-156-02) * 2 mL in 1 SYRINGE
TRELSTAR
triptorelin pamoate
INJECTABLE;INTRAMUSCULAR 022437 NDA Actavis Pharma, Inc. 52544-156 52544-156-02 2 mL in 1 VIAL, SINGLE-DOSE (52544-156-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULARStrengthEQ 22.5MG BASE/VIAL
Approval Date:Mar 10, 2010TE:RLD:Yes
Patent:5,776,885Patent Expiration:Jul 7, 2015Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 022437

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan Sales Llc
TRELSTAR
triptorelin pamoate
INJECTABLE;INTRAMUSCULAR022437-001Mar 10, 20105,776,885► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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