TEMIXYS
- Product NDC
- 32228-004
- 11-digit product format
- 322280004
- Labeler code
- 32228
- Product ID
- 32228-004_9e1f1f00-f7b5-4beb-b4ef-2fe85a5dfdbb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lamivudine and tenofovir disoproxil fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- CELLTRION, INC.
- Application
- NDA211284
- Marketing category
- NDA
- Marketing start
- 2018-11-16
- Marketing end
- 0000-00-00
- Substance
- LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
- Active strength
- 300 mg/1; mg/1
- Pharmacologic classes
- Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record