Dolutegravir
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Approved
Approval ID
1b045960-02a9-45a2-8393-66c0f8da58ef
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 5, 2021
Manufacturers
FDA
Mylan Laboratories Limited
DUNS: 650547156
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dolutegravir
PRODUCT DETAILS
NDC Product Code65015-353
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationORAL
Effective DateMarch 5, 2021
Generic NameDolutegravir
INGREDIENTS (15)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
DOLUTEGRAVIR SODIUMActive
Quantity: 10 mg in 1 1
Code: 1Q1V9V5WYQ
Classification: ACTIM
CALCIUM SULFATE DIHYDRATEInactive
Code: 4846Q921YM
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT