TEMIXYS
- Product NDC
- 72606-002
- 11-digit product format
- 726060002
- Labeler code
- 72606
- Product ID
- 72606-002_0732cedf-911f-4b66-b610-3790d1df6b9e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lamivudine and tenofovir disoproxil fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- CELLTRION USA, 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],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 72606-002-01 | 72606000201 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72606-002-01) | 2019-11-07 | 0000-00-00 | No | No | Current |