Last Updated: September 24, 2026

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 two suppliers. 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 is one drug master file entry for this compound. Seventeen 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

Medical Subject Heading (MeSH) Categories for 205054

Antineoplastic Agents, Hormonal
Fertility Agents, Female

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)
LEUPROLIDE ACETATE FOR DEPOT SUSPENSION	leuprolide acetate	FOR SUSPENSION;INTRAMUSCULAR	205054	NDA	Avyxa Pharma, LLC	83831-134	83831-134-01	1 KIT in 1 CARTON (83831-134-01) * 2 mL in 1 VIAL, SINGLE-DOSE (83831-150-22) * 2 mL in 1 SYRINGE (83831-135-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;INTRAMUSCULAR			Strength	22.5MG/VIAL
Approval Date:	Aug 28, 2018	TE:		RLD:	Yes

Expired US Patents for NDA 205054

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Invagen Pharms	LEUPROLIDE ACETATE FOR DEPOT SUSPENSION	leuprolide acetate	FOR SUSPENSION;INTRAMUSCULAR	205054-001	Aug 28, 2018	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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