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 for oral use Initial U.S. Approval 2008
Approved
Approval ID
73667241-b95a-49b0-9c51-a4289f20d5c2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 2, 2013
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
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 Code54868-5864
Application NumberNDA022187
Product Classification
M
Marketing Category
C73594
G
Generic Name
etravirine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 2, 2013
FDA Product Classification
INGREDIENTS (7)
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
etravirineActive
Quantity: 100 mg in 1 1
Code: 0C50HW4FO1
Classification: ACTIB
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
etravirine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6368
Application NumberNDA022187
Product Classification
M
Marketing Category
C73594
G
Generic Name
etravirine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 2, 2013
FDA Product Classification
INGREDIENTS (6)
etravirineActive
Quantity: 200 mg in 1 1
Code: 0C50HW4FO1
Classification: ACTIB
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT