Dolutegravir

DOLUTEGRAVIR- dolutegravir sodium tablet, for suspension
Mylan Laboratories Limited

PRINCIPAL DISPLAY PANEL – 10 mg

Dolutegravir Tablets for Oral Suspension 10 mg Bottle Label
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DOLUTEGRAVIR
dolutegravir tablet, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NHRIC:65015-353
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOLUTEGRAVIR SODIUM (DOLUTEGRAVIR) DOLUTEGRAVIR 10 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM SULFATE DIHYDRATE
CROSPOVIDONE
MANNITOL
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A CORN
SUCRALOSE
SODIUM STEARYL FUMARATE
FERROSOFERRIC OXIDE
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL 400
FERRIC OXIDE RED
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color PINK Score 2 pieces
Shape OVAL Size 12mm
Flavor STRAWBERRY (strawberry cream) Imprint Code D;T;M
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NHRIC:65015-353-14 30 TABLET, FOR SUSPENSION in 1 BOTTLE, PLASTIC None
2 NHRIC:65015-353-17 60 TABLET, FOR SUSPENSION in 1 BOTTLE, PLASTIC None
3 NHRIC:65015-353-18 90 TABLET, FOR SUSPENSION in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Export only 11/19/2020
Labeler — Mylan Laboratories Limited (650547156)

Revised: 03/2021 Mylan Laboratories Limited

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