Savella (Page 7 of 7)

SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED SAVELLA (MILNACIPRAN HYDROCHLORIDE) KIT

Label Image
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SAVELLA
milnacipran hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50436-9993(NDC:0456-1525)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MILNACIPRAN HYDROCHLORIDE (MILNACIPRAN) MILNACIPRAN HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
POVIDONE, UNSPECIFIED
carboxymethylcellulose calcium
silicon dioxide
magnesium stearate
talc
POLYETHYLENE GLYCOL, UNSPECIFIED
titanium dioxide
POLYVINYL ALCOHOL, UNSPECIFIED
Product Characteristics
Color white (white) Score no score
Shape ROUND (ROUND) Size 6mm
Flavor Imprint Code FL;25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50436-9993-2 60 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022256 04/17/2009
Labeler — Unit Dose Services (831995316)
Establishment
Name Address ID/FEI Operations
Unit Dose Services 831995316 REPACK (50436-9993), RELABEL (50436-9993)

Revised: 03/2017 Unit Dose Services

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