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Generated: April 25, 2019

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Details for New Drug Application (NDA): 205054

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NDA 205054 describes LUTRATE DEPOT KIT, which is a drug marketed by Gp-pharm Sa and is included in one NDA. There is one patent protecting this drug. Additional details are available on the LUTRATE DEPOT KIT profile page.

The generic ingredient in LUTRATE DEPOT KIT is leuprolide acetate. There are twenty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.
Summary for 205054
Tradename:LUTRATE DEPOT KIT
Applicant:Gp-pharm Sa
Ingredient:leuprolide acetate
Patents:1
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 205054

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;INTRAMUSCULARStrength22.5MG/VIAL
Approval Date:Aug 28, 2018TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Dec 15, 2020Product Flag?YSubstance Flag?Delist Request?

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