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Generated: August 16, 2017

DrugPatentWatch Database Preview

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-one drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.

Summary for NDA: 020011

Tradename:
1
Applicant:
1
Ingredient:
1
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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:Yes

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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie Endocrine Inc
LUPRON DEPOT
leuprolide acetate
INJECTABLE;INJECTION020011-001Oct 22, 1990► Subscribe► Subscribe
Abbvie Endocrine Inc
LUPRON DEPOT
leuprolide acetate
INJECTABLE;INJECTION020011-001Oct 22, 1990► Subscribe► Subscribe
Abbvie Endocrine Inc
LUPRON DEPOT
leuprolide acetate
INJECTABLE;INJECTION020011-001Oct 22, 1990► Subscribe► Subscribe
Abbvie Endocrine Inc
LUPRON DEPOT
leuprolide acetate
INJECTABLE;INJECTION020011-001Oct 22, 1990► Subscribe► Subscribe
Abbvie Endocrine Inc
LUPRON DEPOT
leuprolide acetate
INJECTABLE;INJECTION020011-001Oct 22, 1990► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Healthtrust
Cipla
Fish and Richardson
Accenture
Chinese Patent Office
Harvard Business School
Cantor Fitzgerald
Moodys
Citi
Colorcon

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 verifification 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.

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