PIFELTRO
These highlights do not include all the information needed to use PIFELTRO safely and effectively. See full prescribing information for PIFELTRO. PIFELTRO (doravirine) tablets, for oral use Initial U.S. Approval: 2018
Approved
Approval ID
76ce1f00-28c0-4314-bd2c-d473fe3d0970
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 14, 2023
Manufacturers
FDA
Merck Sharp & Dohme LLC
DUNS: 118446553
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
doravirine
PRODUCT DETAILS
NDC Product Code0006-3069
Application NumberNDA210806
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateNovember 14, 2023
Generic Namedoravirine
INGREDIENTS (11)
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
doravirineActive
Quantity: 100 mg in 1 1
Code: 913P6LK81M
Classification: ACTIB
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
hypromellose acetate succinate 06081224 (3 MM2/S)Inactive
Code: 6N003M473W
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
carnauba waxInactive
Code: R12CBM0EIZ
Classification: IACT
hypromellose, unspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
triacetinInactive
Code: XHX3C3X673
Classification: IACT