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Generated: November 16, 2018

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Details for New Drug Application (NDA): 022256

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NDA 022256 describes SAVELLA, which is a drug marketed by Allergan Sales Llc and is included in one NDA. It is available from five suppliers. There are four patents 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-seven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the milnacipran hydrochloride profile page.
Summary for 022256
Tradename:SAVELLA
Applicant:Allergan Sales Llc
Ingredient:milnacipran hydrochloride
Patents:4
Formulation / Manufacturing:see details
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:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Jan 14, 2023Product Flag?Substance Flag?Delist Request?
Patented Use:MANAGEMENT OF FIBROMYALGIA (FM)
Patent:➤ Sign UpPatent Expiration:Nov 5, 2021Product Flag?Substance Flag?Delist Request?
Patented Use:MANAGEMENT OF FIBROMYALGIA (FM)
Patent:➤ Sign UpPatent Expiration:Nov 5, 2021Product Flag?Substance Flag?Delist Request?
Patented Use:MANAGEMENT OF FIBROMYALGIA (FM)

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