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Last Updated: November 2, 2024

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
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:RXDosage:TABLET;ORALStrength12.5MG
Approval Date:Jan 14, 2009TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Sep 19, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:MANAGEMENT OF FIBROMYALGIA

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Jan 14, 2009TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Sep 19, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:MANAGEMENT OF FIBROMYALGIA

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jan 14, 2009TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Sep 19, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:MANAGEMENT OF FIBROMYALGIA

Expired US Patents for NDA 022256

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie SAVELLA milnacipran hydrochloride TABLET;ORAL 022256-002 Jan 14, 2009 ⤷  Sign Up ⤷  Sign Up
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 022256-004 Jan 14, 2009 ⤷  Sign Up ⤷  Sign Up
Abbvie SAVELLA milnacipran hydrochloride TABLET;ORAL 022256-003 Jan 14, 2009 ⤷  Sign Up ⤷  Sign Up
Abbvie SAVELLA milnacipran hydrochloride TABLET;ORAL 022256-003 Jan 14, 2009 ⤷  Sign Up ⤷  Sign Up
Abbvie SAVELLA milnacipran hydrochloride TABLET;ORAL 022256-004 Jan 14, 2009 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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