DOLUTEGRAVIR- dolutegravir tablet, for suspension 
Mylan Laboratories Limited

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PRINCIPAL DISPLAY PANEL – 10 mg

Dolutegravir Tablets for Oral Suspension 10 mg Bottle Label
DOLUTEGRAVIR 
dolutegravir tablet, for suspension
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65015-353
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOLUTEGRAVIR SODIUM (UNII: 1Q1V9V5WYQ) (DOLUTEGRAVIR - UNII:DKO1W9H7M1) DOLUTEGRAVIR10 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM SULFATE DIHYDRATE (UNII: 4846Q921YM)  
CROSPOVIDONE (UNII: 2S7830E561)  
MANNITOL (UNII: 3OWL53L36A)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE K30 (UNII: U725QWY32X)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColorPINKScore2 pieces
ShapeOVALSize12mm
FlavorSTRAWBERRY (strawberry cream) Imprint Code D;T;M
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65015-353-1430 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2020
2NDC:65015-353-1760 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2020
3NDC:65015-353-1890 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only11/19/2020
Labeler - Mylan Laboratories Limited (650547156)

Revised: 3/2021
Document Id: 7a748c3a-10d0-444d-9e97-55e85344d7ee
Set id: 1b045960-02a9-45a2-8393-66c0f8da58ef
Version: 2
Effective Time: 20210305
 
Mylan Laboratories Limited