Details for New Drug Application (NDA): 020263

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NDA 020263 describes LUPRON DEPOT-PED KIT, which is a drug marketed by Abbvie Endocrine Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the LUPRON DEPOT-PED KIT profile page.

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

Summary for 020263

Tradename:	LUPRON DEPOT-PED KIT
Applicant:	Abbvie Endocrine Inc
Ingredient:	leuprolide acetate
Patents:	2

Medical Subject Heading (MeSH) Categories for 020263

Antineoplastic Agents, Hormonal
Fertility Agents, Female

Suppliers and Packaging for NDA: 020263

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263	NDA	AbbVie Inc.	0074-2108	0074-2108-03	1 KIT in 1 CARTON (0074-2108-03) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET
LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263	NDA	AbbVie Inc.	0074-2282	0074-2282-03	1 KIT in 1 CARTON (0074-2282-03) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAMUSCULAR			Strength	7.5MG
Approval Date:	Apr 16, 1993	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	POWDER;INTRAMUSCULAR			Strength	3.75MG,7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Apr 16, 1993	TE:		RLD:	Yes

Profile for product number 004

Active Rx/OTC/Discontinued:	DISCN	Dosage:	POWDER;INTRAMUSCULAR			Strength	7.5MG,7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Apr 16, 1993	TE:		RLD:	Yes

Expired US Patents for NDA 020263

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-005	Jan 21, 1994	⤷ Sign Up	⤷ Sign Up
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-004	Apr 16, 1993	⤷ Sign Up	⤷ Sign Up
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-008	Aug 15, 2011	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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