Details for New Drug Application (NDA): 022343
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NDA 022343 describes EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE, which is a drug marketed by Aurobindo Pharma Ltd, Laurus, and Macleods Pharms Ltd, and is included in four NDAs. It is available from one supplier. Additional details are available on the EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE profile page.
The generic ingredient in EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE is efavirenz; lamivudine; tenofovir disoproxil fumarate. There are twenty-six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the efavirenz; lamivudine; tenofovir disoproxil fumarate profile page.
The generic ingredient in EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE is efavirenz; lamivudine; tenofovir disoproxil fumarate. There are twenty-six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the efavirenz; lamivudine; tenofovir disoproxil fumarate profile page.
Summary for 022343
| Tradename: | EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | efavirenz; lamivudine; tenofovir disoproxil fumarate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 600MG;300MG;300MG | ||||
| Approval Date: | Aug 15, 2018 | TE: | RLD: | Yes | |||||
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