SOTYLIZE (Page 7 of 7)

PRINCIPAL DISPLAY PANEL — 250 mL Bottle Label

NDC: 24338-530-25

Sotylize®
(sotalol hydrochloride) oral solution

5 mg/mL

For Oral Use Only

250 mL

Distributed by:
arbor
PHARMACEUTICALS, LLCAtlanta, GA 30328

Principal Display Panel -- 250 mL Bottle Label
(click image for full-size original)
SOTYLIZE sotalol hydrochloride solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24338-530
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SOTALOL HYDROCHLORIDE (SOTALOL) SOTALOL HYDROCHLORIDE 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CITRATE, UNSPECIFIED FORM
CITRIC ACID MONOHYDRATE
SUCRALOSE
SODIUM BENZOATE
WATER
Product Characteristics
Color Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24338-530-25 250 mL in 1 BOTTLE None
2 NDC:24338-530-48 480 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205108 03/01/2015
Labeler — Arbor Pharmaceuticals, Inc. (781796417)

Revised: 12/2018 Arbor Pharmaceuticals, Inc.

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