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Last Updated: March 28, 2024

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. 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. Additional details are available on the leuprolide acetate; norethindrone acetate profile page.
Summary for 203696

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage: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:DISCNDosage: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 Trial ⤷  Try a Trial
Abbvie Endocrine LUPANETA PACK leuprolide acetate; norethindrone acetate INJECTABLE, TABLET;INTRAMUSCULAR, ORAL 203696-002 Dec 14, 2012 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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