DOLUTEGRAVIR- dolutegravir tablet, for suspension
Mylan Laboratories Limited
----------
PRINCIPAL DISPLAY PANEL – 10 mg
DOLUTEGRAVIR
dolutegravir tablet, for suspension
Product Information
Product Type
HUMAN PRESCRIPTION DRUG
Item Code (Source)
NDC:65015-353
Route of Administration
ORAL
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
DOLUTEGRAVIR SODIUM
(UNII: 1Q1V9V5WYQ) (DOLUTEGRAVIR - UNII:DKO1W9H7M1)
DOLUTEGRAVIR
10 mg
Inactive Ingredients
Ingredient Name
Strength
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
Color
PINK
Score
2 pieces
Shape
OVAL
Size
12mm
Flavor
STRAWBERRY (strawberry cream)
Imprint Code
D;T;M
Contains
Packaging
#
Item Code
Package Description
Marketing Start Date
Marketing End Date
1
NDC:65015-353-14
30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
11/19/2020
2
NDC:65015-353-17
60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
11/19/2020
3
NDC:65015-353-18
90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
11/19/2020
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: 3/2021
Document Id:
7a748c3a-10d0-444d-9e97-55e85344d7ee
34391-3
Set id: 1b045960-02a9-45a2-8393-66c0f8da58ef
Version: 2
Effective Time: 20210305
Mylan Laboratories Limited