Lacosamide: Package Insert and Label Information (Page 5 of 5)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

465 mL Bottle Label
NDC 42934- 303 -32
Lacosamide Oral solution CV
10 mg / mL

Rx Only
ATTENTION PHARMACIST:
Each patient is required to receive
the accompanying Medication Guide.

Manufactured By:

Medley Pharmaceuticals Ltd.

Plot No. 18 and 19, Survey No. 378 / 7 & 8, 379 / 2 & 3,

Zari Causeway Road, Kachigam, Daman — 396210, INDIA.

200 mL Bottle Label
NDC 42934- 303 -31
Lacosamide Oral solution CV
10 mg / mL
Rx Only
ATTENTION PHARMACIST:
Each patient is required to receive
the accompanying Medication Guide.

Manufactured By:

Medley Pharmaceuticals Ltd.

Plot No. 18 and 19, Survey No. 378 / 7 & 8, 379 / 2 & 3,

Zari Causeway Road, Kachigam, Daman — 396210, INDIA.

LACOSAMIDE lacosamide solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42934-303 Route of Administration ORAL DEA Schedule CV

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LACOSAMIDE (LACOSAMIDE) LACOSAMIDE 10 mg in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN ACESULFAME POTASSIUM METHYLPARABEN ANHYDROUS CITRIC ACID SODIUM CHLORIDE CARBOXYMETHYLCELLULOSE SODIUM NONCRYSTALLIZING SORBITOL SOLUTION POLYETHYLENE GLYCOL 4000

Product Characteristics Color yellow (Clear,colourless to yellow or yellow-brown) Score Shape Size Flavor STRAWBERRY Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:42934-303-31 200 mL in 1 BOTTLE, PLASTIC None 2 NDC:42934-303-32 465 mL in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA216461 08/12/2021

Labeler — Medley Pharmaceuticals Limited (677602480)

Registrant — Medley Pharmaceuticals Limited (677602480)

Establishment
Name	Address	ID/FEI	Operations
Medley Pharmaceuticals Limited		677602480	manufacture (42934-303)

Revised: 02/2023 Medley Pharmaceuticals Limited