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Last Updated: March 27, 2023

Details for New Drug Application (NDA): 019732

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NDA 019732 describes LUPRON DEPOT, which is a drug marketed by Abbvie Endocrine Inc and is included in five NDAs. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the LUPRON DEPOT profile page.

The generic ingredient in LUPRON DEPOT is leuprolide acetate. There are twenty-two drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.

Summary for 019732

Tradename:	LUPRON DEPOT
Applicant:	Abbvie Endocrine Inc
Ingredient:	leuprolide acetate
Patents:	0
Formulation / Manufacturing:	see details

Medical Subject Heading (MeSH) Categories for 019732

Antineoplastic Agents, Hormonal
Fertility Agents, Female

Suppliers and Packaging for NDA: 019732

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	019732	NDA	AbbVie Inc.	0074-3642	0074-3642-03	1 KIT in 1 CARTON (0074-3642-03) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	7.5MG/VIAL
Approval Date:	Jan 26, 1989	TE:		RLD:	Yes

Expired US Patents for NDA 019732

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	019732-001	Jan 26, 1989	See Plans and Pricing	See Plans and Pricing
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	019732-001	Jan 26, 1989	See Plans and Pricing	See Plans and Pricing
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	019732-001	Jan 26, 1989	See Plans and Pricing	See Plans and Pricing
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	019732-001	Jan 26, 1989	See Plans and Pricing	See Plans and Pricing
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	019732-001	Jan 26, 1989	See Plans and Pricing	See Plans and Pricing
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	019732-001	Jan 26, 1989	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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