59676-800 : Symtuza Oral Tablet, Film Coated

Labeler: Janssen Products Lp
Product Type: Human Prescription Drug
Drug Name:  Symtuza
Dosage Form: Oral Tablet, Film Coated
Application #: NDA210455
Rev. Date: 

NDC Package Codes:

  • 59676-800-30: 30 TABLET, FILM COATED IN 1 BOTTLE (59676‑800‑30)
  • 59676-800-99: 30 TABLET, FILM COATED IN 1 BOTTLE (59676‑800‑99)

Active Ingredients:

  • Darunavir
  • Cobicistat
  • Emtricitabine
  • Tenofovir Alafenamide

Dosage Strength:

  • 800 mg
  • 150 mg
  • 200 mg
  • 10 mg

Pharmaceutical Classes:

  • HIV Protease Inhibitors [MoA]
  • Protease Inhibitor [EPC]
  • Cytochrome P450 3A Inhibitors [MoA]
  • Cytochrome P450 2D6 Inhibitors [MoA]
  • Cytochrome P450 3A Inhibitor [EPC]
  • P-Glycoprotein Inhibitors [MoA]
  • Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]
  • Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]
  • Breast Cancer Resistance Protein Inhibitors [MoA]
  • Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
  • Nucleosides [CS]
  • Nucleoside Reverse Transcriptase Inhibitors [MoA]
  • Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]


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