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Serving 500+ biopharmaceutical companies globally:

Johnson and Johnson
Queensland Health
Fish and Richardson

Generated: August 23, 2017

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. Nine suppliers are listed for this compound. Additional details are available on the estradiol; norethindrone acetate profile page.

Summary for NDA: 020907

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
estradiol; norethindrone acetate
TABLET;ORAL 020907 NDA Novo Nordisk 0169-5174 0169-5174-01 5 CARTON in 1 CELLO PACK (0169-5174-01) > 1 DIALPACK in 1 CARTON > 28 TABLET, FILM COATED in 1 DIALPACK
estradiol; norethindrone acetate
TABLET;ORAL 020907 NDA Novo Nordisk 0169-5174 0169-5174-02 1 DIALPACK in 1 CARTON (0169-5174-02) > 28 TABLET, FILM COATED in 1 DIALPACK

Summary for product number 001

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

Summary for product number 002

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

Expired Orange Book Patents for NDA: 020907

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Amneal Pharms Llc
estradiol; norethindrone acetate
TABLET;ORAL020907-001Nov 18, 1998► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Express Scripts
Cantor Fitzgerald
Harvard Business School
Queensland Health
Boehringer Ingelheim
Argus Health
Farmers Insurance

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