Details for New Drug Application (NDA): 022256

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NDA 022256 describes SAVELLA, which is a drug marketed by Abbvie and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the SAVELLA profile page.

The generic ingredient in SAVELLA is milnacipran hydrochloride. There are twenty-eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the milnacipran hydrochloride profile page.

Summary for 022256

Tradename:	SAVELLA
Applicant:	Abbvie
Ingredient:	milnacipran hydrochloride
Patents:	1

Pharmacology for NDA: 022256

Mechanism of Action	Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 022256

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256	NDA	Allergan, Inc.	0456-1500	0456-1500-55	1 BLISTER PACK in 1 CARTON (0456-1500-55) / 1 KIT in 1 BLISTER PACK
SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256	NDA	Allergan, Inc.	0456-1510	0456-1510-60	60 TABLET, FILM COATED in 1 BOTTLE (0456-1510-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	12.5MG
Approval Date:	Jan 14, 2009	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Sep 19, 2029	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	MANAGEMENT OF FIBROMYALGIA

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Jan 14, 2009	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Sep 19, 2029	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	MANAGEMENT OF FIBROMYALGIA

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Jan 14, 2009	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Sep 19, 2029	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	MANAGEMENT OF FIBROMYALGIA

Expired US Patents for NDA 022256

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-004	Jan 14, 2009	⤷ Sign Up	⤷ Sign Up
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-001	Jan 14, 2009	⤷ Sign Up	⤷ Sign Up
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-002	Jan 14, 2009	⤷ Sign Up	⤷ Sign Up
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-002	Jan 14, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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