Efavirenz, emtricitabine 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; Emtricitabine; Tenofovir Disoproxil Fumarate.
| Product ID | 42385-915_aca22076-f435-4533-9fcf-566b0734c313 |
| NDC | 42385-915 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Efavirenz, emtricitabine and tenofovir disoproxil fumarate |
| Generic Name | Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2021-12-22 |
| Marketing Category | ANDA / |
| Application Number | ANDA213541 |
| Labeler Name | Laurus Labs Limited |
| Substance Name | EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
| Active Ingredient Strength | 600 mg/1; mg/1; mg/1 |
| Pharm Classes | 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],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],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 | N |
| Listing Certified Through | 2022-12-31 |
| Marketing Start Date | 2021-12-22 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0093-5234 | Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate | Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate |
| 31722-736 | Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate | Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate |
| 33342-138 | Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate | Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate |
| 42385-915 | Efavirenz, emtricitabine and tenofovir disoproxil fumarate | Efavirenz, emtricitabine and tenofovir disoproxil fumarate |
| 65862-497 | Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate | Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate |
| 69097-210 | efavirenz, emtricitabine and tenofovir disoproxil fumarate | efavirenz, emtricitabine and tenofovir disoproxil fumarate |
| 70518-2905 | Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate | Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate |
| 76282-678 | efavirenz, emtricitabine and tenofovir disoproxil fumarate | efavirenz, emtricitabine and tenofovir disoproxil fumarate |