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Fish and Richardson
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Accenture
Julphar
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Federal Trade Commission

Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203696

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NDA 203696 describes LUPANETA PACK, which is a drug marketed by Abbvie Endocrine and is included in one NDA. It is available from one supplier. Additional details are available on the LUPANETA PACK profile page.

The generic ingredient in LUPANETA PACK is leuprolide acetate; norethindrone acetate. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the leuprolide acetate; norethindrone acetate profile page.
Summary for 203696
Tradename:LUPANETA PACK
Applicant:Abbvie Endocrine
Ingredient:leuprolide acetate; norethindrone acetate
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 203696
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LUPANETA PACK leuprolide acetate; norethindrone acetate INJECTABLE, TABLET;INTRAMUSCULAR, ORAL 203696 NDA AbbVie Inc. 0074-1052 N 0074-1052-05
LUPANETA PACK leuprolide acetate; norethindrone acetate INJECTABLE, TABLET;INTRAMUSCULAR, ORAL 203696 NDA AbbVie Inc. 0074-1052 N 0074-1052-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE, TABLET;INTRAMUSCULAR, ORALStrength3.75MG/VIAL,N/A;N/A,5MG
Approval Date:Dec 14, 2012TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE, TABLET;INTRAMUSCULAR, ORALStrength11.25MG/VIAL,N/A;N/A,5MG
Approval Date:Dec 14, 2012TE:RLD:Yes

Expired US Patents for NDA 203696

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie Endocrine LUPANETA PACK leuprolide acetate; norethindrone acetate INJECTABLE, TABLET;INTRAMUSCULAR, ORAL 203696-001 Dec 14, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Abbvie Endocrine LUPANETA PACK leuprolide acetate; norethindrone acetate INJECTABLE, TABLET;INTRAMUSCULAR, ORAL 203696-002 Dec 14, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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McKinsey
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Dow
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Harvard Business School
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