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FDA Approval

LEXIVA

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

FDA Approval Summary

Effective Date
January 10, 2015
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Fosamprenavir(700 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

State of Florida DOH Central Pharmacy

State of Florida DOH Central Pharmacy

829348114

Products1

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

LEXIVA

Product Details

NDC Product Code
53808-1010
Application Number
NDA021548
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
January 10, 2015
Code: ID1GU2627NClass: ACTIRQuantity: 700 mg in 1 1
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
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