Details for New Drug Application (NDA): 213926
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NDA 213926 describes EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE, which is a drug marketed by Apotex and Lupin Ltd and is included in two NDAs. Additional details are available on the EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE profile page.
The generic ingredient in EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE is emtricitabine; tenofovir alafenamide fumarate. There are eighteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the emtricitabine; tenofovir alafenamide fumarate profile page.
The generic ingredient in EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE is emtricitabine; tenofovir alafenamide fumarate. There are eighteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the emtricitabine; tenofovir alafenamide fumarate profile page.
Summary for 213926
| Tradename: | EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE |
| Applicant: | Lupin Ltd |
| Ingredient: | emtricitabine; tenofovir alafenamide fumarate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG;EQ 25MG BASE | ||||
| Approval Date: | Dec 13, 2024 | TE: | AB | RLD: | No | ||||
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