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LEXIVA

These highlights do not include all the information needed to use LEXIVA safely and effectively. See full prescribing information for LEXIVA.LEXIVA (fosamprenavir calcium) Tablets, for oral useLEXIVA (fosamprenavir calcium) Oral SuspensionInitial U.S. Approval: 2003

Approved
Approval ID

b919bb7e-75f8-4df4-924c-54e829be0607

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 10, 2015

Manufacturers
FDA

State of Florida DOH Central Pharmacy

DUNS: 829348114

Products 1

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

fosamprenavir calcium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code53808-1010
Application NumberNDA021548
Product Classification
M
Marketing Category
C73594
G
Generic Name
fosamprenavir calcium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2015
FDA Product Classification

INGREDIENTS (10)

FOSAMPRENAVIR CALCIUMActive
Quantity: 700 mg in 1 1
Code: ID1GU2627N
Classification: ACTIR
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT

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LEXIVA - FDA Drug Approval Details