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
6084e889-6092-4d8d-b7d0-18aae29b6817
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-6237
Application NumberNDA210806
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateJune 13, 2022
Generic Namedoravirine
INGREDIENTS (11)
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
triacetinInactive
Code: XHX3C3X673
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
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
hypromellose, unspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
carnauba waxInactive
Code: R12CBM0EIZ
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT