Details for New Drug Application (NDA): 214053
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NDA 214053 describes EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE, which is a drug marketed by Apotex and is included in one NDA. 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. One supplier is 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. One supplier is listed for this compound. Additional details are available on the emtricitabine; tenofovir alafenamide fumarate profile page.
Summary for 214053
| Tradename: | EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE |
| Applicant: | Apotex |
| Ingredient: | emtricitabine; tenofovir alafenamide fumarate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 120MG;EQ 15MG BASE | ||||
| Approval Date: | May 17, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG;EQ 25MG BASE | ||||
| Approval Date: | May 17, 2024 | TE: | AB | RLD: | No | ||||
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