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Details for New Drug Application (NDA): 020011

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NDA 020011 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 four 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 drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.

Summary for NDA: 020011

Tradename:
LUPRON DEPOT
Applicant:
Abbvie Endocrine Inc
Ingredient:
leuprolide acetate
Patents:0
Therapeutic Class:Hormonal Agents, Suppressant (Pituitary)
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 020011

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LUPRON DEPOT
leuprolide acetate
INJECTABLE;INJECTION 020011 NDA AbbVie Inc. 0074-3641 0074-3641-03 1 KIT in 1 CARTON (0074-3641-03) * 1 mL in 1 SYRINGE * 1 mL in 1 PACKET
LUPRON DEPOT
leuprolide acetate
INJECTABLE;INJECTION 020011 NDA AbbVie Inc. 0074-3641 0074-3641-71 1 KIT in 1 CARTON (0074-3641-71) * 1 mL in 1 SYRINGE * 1 mL in 1 PACKET

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Oct 22, 1990TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength3.75MG
Approval Date:Oct 26, 1995TE:RLD:Yes

Expired Orange Book Patents for NDA: 020011

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie Endocrine Inc
LUPRON DEPOT
leuprolide acetate
INJECTABLE;INJECTION020011-001Oct 22, 19905,575,987► subscribe
Abbvie Endocrine Inc
LUPRON DEPOT
leuprolide acetate
INJECTABLE;INJECTION020011-001Oct 22, 19905,716,640► subscribe
Abbvie Endocrine Inc
LUPRON DEPOT
leuprolide acetate
INJECTABLE;INJECTION020011-001Oct 22, 19904,005,063► subscribe
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