Details for New Drug Application (NDA): 020907

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NDA 020907 describes ACTIVELLA, which is a drug marketed by Amneal and is included in one NDA. It is available from two 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
Ingredient:	estradiol; norethindrone acetate
Patents:	0

Pharmacology for NDA: 020907

Mechanism of Action	Estrogen 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	Amneal Pharmaceuticals LLC	60846-231	60846-231-01	1 BLISTER PACK in 1 CARTON (60846-231-01) / 28 TABLET, FILM COATED in 1 BLISTER PACK
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:	RX	Dosage:	TABLET;ORAL			Strength	1MG;0.5MG
Approval Date:	Nov 18, 1998	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 28, 2006	TE:		RLD:	Yes

Expired US Patents for NDA 020907

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Amneal	ACTIVELLA	estradiol; norethindrone acetate	TABLET;ORAL	020907-001	Nov 18, 1998	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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