MedPath
FDA Approval

Symtuza

August 18, 2023

HUMAN PRESCRIPTION DRUG LABEL

Darunavir(800 mg in 1 1)
Emtricitabine(200 mg in 1 1)
Cobicistat(150 mg in 1 1)
Tenofovir alafenamide(10 mg in 1 1)

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
Code: G70B4ETF4SClass: ACTIBQuantity: 200 mg in 1 1
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
Code: EL9943AG5JClass: ACTIRQuantity: 10 mg in 1 1

Drug Labeling Information

RECENT MAJOR CHANGES SECTION

RECENT MAJOR CHANGES

Contraindications ( 4)

04/2022


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