Details for New Drug Application (NDA): 091612
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NDA 091612 describes TENOFOVIR DISOPROXIL FUMARATE, which is a drug marketed by Aurobindo Pharma, Casi Pharms Inc, Chartwell, Cipla, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Mylan, Mylan Labs Ltd, Qilu, Reyoung, Strides Pharma, and Teva Pharms Usa, and is included in twelve NDAs. It is available from fourteen 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. Fifteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the tenofovir disoproxil fumarate profile page.
Summary for 091612
| Tradename: | TENOFOVIR DISOPROXIL FUMARATE |
| Applicant: | Teva Pharms Usa |
| Ingredient: | tenofovir disoproxil fumarate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
| Approval Date: | Mar 18, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
| Approval Date: | Jan 26, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Jan 26, 2018 | TE: | AB | RLD: | No | ||||
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