Details for New Drug Application (NDA): 203041
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The generic ingredient in EFAVIRENZ, EMTRICITABINE, AND 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 203041
Tradename: | EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE |
Applicant: | Aurobindo Pharma |
Ingredient: | efavirenz; emtricitabine; tenofovir disoproxil fumarate |
Patents: | 0 |
Suppliers and Packaging for NDA: 203041
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE | efavirenz; emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 203041 | ANDA | Aurobindo Pharma Limited | 65862-497 | 65862-497-30 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-497-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG;200MG;300MG | ||||
Approval Date: | Sep 4, 2018 | TE: | AB | RLD: | No |
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