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Last Updated: January 16, 2021

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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 Verity and is included in three NDAs. 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. Additional details are available on the triptorelin pamoate profile page.
Summary for 022437
Tradename:TRELSTAR
Applicant:Verity
Ingredient:triptorelin pamoate
Patents:1
Generic Entry Opportunity Date for 022437
Generic Entry Date for 022437*:
Constraining patent/regulatory exclusivity:
Dosage:
INJECTABLE;INTRAMUSCULAR

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Medical Subject Heading (MeSH) Categories for 022437

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULARStrengthEQ 22.5MG BASE/VIAL
Approval Date:Mar 10, 2010TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jun 30, 2029Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
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Merck
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Medtronic

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