Details for New Drug Application (NDA): 090647
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NDA 090647 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 090647
| Tradename: | TENOFOVIR DISOPROXIL FUMARATE |
| Applicant: | Aurobindo Pharma |
| Ingredient: | tenofovir disoproxil fumarate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 090647
| Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 090647
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TENOFOVIR DISOPROXIL FUMARATE | tenofovir disoproxil fumarate | TABLET;ORAL | 090647 | ANDA | Aurobindo Pharma Limited | 65862-421 | 65862-421-30 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-421-30) |
| TENOFOVIR DISOPROXIL FUMARATE | tenofovir disoproxil fumarate | TABLET;ORAL | 090647 | ANDA | Aurobindo Pharma Limited | 65862-818 | 65862-818-03 | 3 BLISTER PACK in 1 CARTON (65862-818-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
| Approval Date: | Jan 26, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Jan 26, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
| Approval Date: | Jan 26, 2018 | TE: | AB | RLD: | No | ||||
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