MedPath
FDA Approval

DESCOVY

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Gilead Sciences, Inc.
DUNS: 185049848
Effective Date
January 13, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Emtricitabine(200 mg in 1 1)
Tenofovir(25 mg in 1 1)

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

DESCOVY

Product Details

NDC Product Code
61958-2002
Application Number
NDA208215
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
January 20, 2022
Code: G70B4ETF4SClass: ACTIBQuantity: 200 mg in 1 1
TenofovirActive
Code: FWF6Q91TZOClass: ACTIRQuantity: 25 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT

DESCOVY

Product Details

NDC Product Code
61958-2005
Application Number
NDA208215
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
January 20, 2022
Code: G70B4ETF4SClass: ACTIBQuantity: 120 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
TenofovirActive
Code: FWF6Q91TZOClass: ACTIRQuantity: 15 mg in 1 1
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
© Copyright 2025. All Rights Reserved by MedPath