Intelence
These highlights do not include all the information needed to use INTELENCE safely and effectively. See full prescribing information for INTELENCE. INTELENCE (etravirine) [Tablets] Initial U.S. Approval – 2008
Approved
Approval ID
1b5a2dc7-0570-4977-876d-88b4176844a1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 6, 2010
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.
Etravirine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0787
Application NumberNDA022187
Product Classification
M
Marketing Category
C73594
G
Generic Name
Etravirine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 6, 2010
FDA Product Classification
INGREDIENTS (7)
ETRAVIRINEActive
Quantity: 100 mg in 1 1
Code: 0C50HW4FO1
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT