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Serving leading biopharmaceutical companies globally:

Fish and Richardson
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Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020907

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NDA 020907 describes ACTIVELLA, which is a drug marketed by Amneal Pharms Llc and is included in one NDA. It is available from three suppliers. Additional details are available on the ACTIVELLA profile page.

The generic ingredient in ACTIVELLA is estradiol; norethindrone acetate. There are seventy-five drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the estradiol; norethindrone acetate profile page.
Summary for 020907
Applicant:Amneal Pharms Llc
Ingredient:estradiol; norethindrone acetate
Formulation / Manufacturing:see details
Pharmacology for NDA: 020907
Suppliers and Packaging for NDA: 020907
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACTIVELLA estradiol; norethindrone acetate TABLET;ORAL 020907 NDA Novo Nordisk 0169-5174 N 0169-5174-01
ACTIVELLA estradiol; norethindrone acetate TABLET;ORAL 020907 NDA Novo Nordisk 0169-5174 N 0169-5174-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG;0.5MG
Approval Date:Nov 18, 1998TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG;0.1MG
Approval Date:Dec 28, 2006TE:ABRLD:Yes

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