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FDA Approval

Darunavir

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

FDA Approval Summary

Company
Effective Date
April 4, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Darunavir(600 mg in 1 1)

Products1

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

Darunavir

Product Details

NDC Product Code
0480-7736
Application Number
ANDA202118
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 1, 2023
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSPOVIDONE (35 .MU.M)Inactive
Code: 40UAA97IT9Class: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
DarunavirActive
Code: KPC4NRB25LClass: ACTIMQuantity: 600 mg in 1 1
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