Details for New Drug Application (NDA): 206569
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NDA 206569 describes TENOFOVIR DISOPROXIL FUMARATE, which is a drug marketed by Aurobindo Pharma, Chartwell, Chartwell Rx, Cipla, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Norvium Bioscience, Qilu, Reyoung, Strides Pharma, and Teva Pharms Usa, and is included in twelve NDAs. It is available from fifteen suppliers. Additional details are available on the TENOFOVIR DISOPROXIL FUMARATE profile page.
The generic ingredient in TENOFOVIR DISOPROXIL FUMARATE is tenofovir disoproxil fumarate. There are forty-two drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the tenofovir disoproxil fumarate profile page.
The generic ingredient in TENOFOVIR DISOPROXIL FUMARATE is tenofovir disoproxil fumarate. There are forty-two drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the tenofovir disoproxil fumarate profile page.
Summary for 206569
| Tradename: | TENOFOVIR DISOPROXIL FUMARATE |
| Applicant: | Norvium Bioscience |
| Ingredient: | tenofovir disoproxil fumarate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
| Approval Date: | Nov 27, 2018 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Nov 27, 2018 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
| Approval Date: | Nov 27, 2018 | TE: | RLD: | No | |||||
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