Details for New Drug Application (NDA): 209061
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NDA 209061 describes EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE, which is a drug marketed by Mylan and is included in one NDA. Additional details are available on the EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE profile page.
The generic ingredient in EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE is efavirenz; emtricitabine; tenofovir disoproxil fumarate. There are twenty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the efavirenz; emtricitabine; tenofovir disoproxil fumarate profile page.
The generic ingredient in EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE is efavirenz; emtricitabine; tenofovir disoproxil fumarate. There are twenty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the efavirenz; emtricitabine; tenofovir disoproxil fumarate profile page.
Summary for 209061
| Tradename: | EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
| Applicant: | Mylan |
| Ingredient: | efavirenz; emtricitabine; tenofovir disoproxil fumarate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 600MG;200MG;300MG | ||||
| Approval Date: | Sep 5, 2024 | TE: | RLD: | No | |||||
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