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Last Updated: March 28, 2024

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. Nine 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
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 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:RXDosage:POWDER;INTRAMUSCULARStrength7.5MG
Approval Date:Apr 16, 1993TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:POWDER;INTRAMUSCULARStrength3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Apr 16, 1993TE:RLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:POWDER;INTRAMUSCULARStrength7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Apr 16, 1993TE:RLD:Yes

Expired US Patents for NDA 020263

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.