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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 205054


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NDA 205054 describes LEUPROLIDE ACETATE FOR DEPOT SUSPENSION, which is a drug marketed by Invagen Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the LEUPROLIDE ACETATE FOR DEPOT SUSPENSION profile page.

The generic ingredient in LEUPROLIDE ACETATE FOR DEPOT SUSPENSION is leuprolide acetate. There are twenty-two drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.
Summary for 205054
Tradename:LEUPROLIDE ACETATE FOR DEPOT SUSPENSION
Applicant:Invagen Pharms
Ingredient:leuprolide acetate
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 205054
Suppliers and Packaging for NDA: 205054
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEUPROLIDE ACETATE FOR DEPOT SUSPENSION leuprolide acetate FOR SUSPENSION;INTRAMUSCULAR 205054 NDA CIPLA USA INC. 69097-909 69097-909-50 1 KIT in 1 CARTON (69097-909-50) * 2 mL in 1 VIAL, SINGLE-DOSE (69097-950-32) * 2 mL in 1 SYRINGE (69097-960-31)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;INTRAMUSCULARStrength22.5MG/VIAL
Approval Date:Aug 28, 2018TE:RLD:Yes

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