Manufacturing Establishments (12)
Gilead Alberta ULC
Janssen Products LP
207452996
Janssen Ortho LLC
Janssen Products LP
805887986
Janssen Cilag SpA
Janssen Products LP
542797928
Janssen Pharmaceuticals, Inc.
Janssen Products LP
868441320
Evonik Operations GmbH
Janssen Products LP
343170605
Janssen Pharmaceutica NV
Janssen Products LP
400345889
Patheon, Inc.
Janssen Products LP
240769596
Janssen Pharmaceutical Sciences Unlimited Company
Janssen Products LP
985639841
Union Quimico Farmaceutica SA (Uquifa)
Janssen Products LP
460940868
Yuhan Chemical, Inc.
Janssen Products LP
687831958
Esteve Quimica, SA
Janssen Products LP
633485529
AMPAC Fine Chemicals
Janssen Products LP
073903937
Products (1)
Symtuza
59676-800
NDA210455
NDA (C73594)
ORAL
August 18, 2023
DarunavirActive
Code: YO603Y8113Class: ACTIBQuantity: 800 mg in 1 1
EmtricitabineActive
Code: G70B4ETF4SClass: ACTIBQuantity: 200 mg in 1 1
CobicistatActive
Code: LW2E03M5PGClass: ACTIBQuantity: 150 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
Tenofovir alafenamideActive
Code: EL9943AG5JClass: ACTIRQuantity: 10 mg in 1 1
Drug Labeling Information
RECENT MAJOR CHANGES SECTION
RECENT MAJOR CHANGES
Contraindications ( 4) |
04/2022 |