Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Laurus Labs Limited. The primary component is Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate.
| Product ID | 42385-928_1f8f9fe1-b8fd-4f65-8832-9d3d6802d076 |
| NDC | 42385-928 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate |
| Generic Name | Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2020-05-14 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA212786 |
| Labeler Name | Laurus Labs Limited |
| Substance Name | EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE |
| Active Ingredient Strength | 600 mg/1; mg/1; mg/1 |
| Pharm 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],Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [EXT],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2020-05-14 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA212786 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-05-14 |
| Marketing Category | ANDA |
| Application Number | ANDA212786 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-05-14 |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 33342-362 | efavirenz, lamivudine and tenofovir disoproxil fumarate | efavirenz, lamivudine and tenofovir disoproxil fumarate |
| 42385-928 | Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate | Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate |
| 42385-929 | Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate | Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate |
| 49502-475 | SYMFI | Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate |
| 49502-425 | SYMFI LO | Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate |