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Details for New Drug Application (NDA): 020263

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

The generic ingredient in LUPRON DEPOT-PED 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: 020263

Tradename:
LUPRON DEPOT-PED
Applicant:
Abbvie Endocrine Inc
Ingredient:
leuprolide acetate
Patents:1
Therapeutic Class:Hormonal Agents, Suppressant (Pituitary)
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 020263

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LUPRON DEPOT-PED
leuprolide acetate
INJECTABLE;INJECTION 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
leuprolide acetate
INJECTABLE;INJECTION 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

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength7.5MG/VIAL
Approval Date:Apr 16, 1993TE:RLD:Yes
Patent:6,036,976Patent Expiration:Dec 13, 2016Product Flag?Substance Flag?Delist Request?

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength3.75MG/VIAL,7.5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Apr 16, 1993TE:RLD:No

Summary for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength7.5MG/VIAL,7.5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Apr 16, 1993TE:RLD:No

Expired Orange Book 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
leuprolide acetate
INJECTABLE;INJECTION020263-002Apr 16, 19934,005,063► subscribe
Abbvie Endocrine Inc
LUPRON DEPOT-PED
leuprolide acetate
INJECTABLE;INJECTION020263-008Aug 15, 20115,643,607► subscribe
Abbvie Endocrine Inc
LUPRON DEPOT-PED
leuprolide acetate
INJECTABLE;INJECTION020263-002Apr 16, 19935,631,021► subscribe
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