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Generated: November 19, 2018

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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 one supplier. Additional details are available on the LUPRON DEPOT-PED profile page.

The generic ingredient in LUPRON DEPOT-PED is leuprolide acetate. There are twenty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.
Summary for 020263
Tradename:LUPRON DEPOT-PED
Applicant:Abbvie Endocrine Inc
Ingredient:leuprolide acetate
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 020263
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 SWAB in 1 PACKET * 1 mL in 1 SYRINGE
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 SWAB in 1 PACKET * 1 mL in 1 SYRINGE

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength7.5MG/VIAL
Approval Date:Apr 16, 1993TE:RLD:Yes

Profile 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:Yes

Profile 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:Yes

Expired US Patents for NDA 020263

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie Endocrine Inc LUPRON DEPOT-PED leuprolide acetate INJECTABLE;INJECTION 020263-005 Jan 21, 1994 ➤ Try a Free Trial ➤ Try a Free Trial
Abbvie Endocrine Inc LUPRON DEPOT-PED leuprolide acetate INJECTABLE;INJECTION 020263-002 Apr 16, 1993 ➤ Try a Free Trial ➤ Try a Free Trial
Abbvie Endocrine Inc LUPRON DEPOT-PED leuprolide acetate INJECTABLE;INJECTION 020263-008 Aug 15, 2011 ➤ Try a Free Trial ➤ Try a Free Trial
Abbvie Endocrine Inc LUPRON DEPOT-PED leuprolide acetate INJECTABLE;INJECTION 020263-005 Jan 21, 1994 ➤ Try a Free Trial ➤ Try a Free Trial
Abbvie Endocrine Inc LUPRON DEPOT-PED leuprolide acetate INJECTABLE;INJECTION 020263-008 Aug 15, 2011 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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