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Last Updated: December 11, 2019

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 020907
Tradename:ACTIVELLA
Applicant:Amneal Pharms Llc
Ingredient:estradiol; norethindrone acetate
Patents:0
Pharmacology for NDA: 020907
Mechanism of ActionEstrogen Receptor Agonists
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 Gemini Laboratories, LLC 60846-202 60846-202-01 1 DIALPACK in 1 CARTON (60846-202-01) > 28 TABLET, FILM COATED in 1 DIALPACK
ACTIVELLA estradiol; norethindrone acetate TABLET;ORAL 020907 NDA Amneal Pharmaceuticals LLC 60846-232 60846-232-01 1 BLISTER PACK in 1 CARTON (60846-232-01) > 28 TABLET, FILM COATED in 1 BLISTER PACK

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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