Details for New Drug Application (NDA): 078800
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NDA 078800 describes TENOFOVIR DISOPROXIL FUMARATE, which is a drug marketed by Aurobindo Pharma, Chartwell, Chartwell Rx, Cipla, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Mylan Labs 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 078800
| Tradename: | TENOFOVIR DISOPROXIL FUMARATE |
| Applicant: | Cipla |
| Ingredient: | tenofovir disoproxil fumarate |
| Patents: | 0 |
Pharmacology for NDA: 078800
| Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 078800
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TENOFOVIR DISOPROXIL FUMARATE | tenofovir disoproxil fumarate | TABLET;ORAL | 078800 | ANDA | Cipla USA Inc. | 69097-533 | 69097-533-02 | 30 TABLET in 1 BOTTLE (69097-533-02) |
| TENOFOVIR DISOPROXIL FUMARATE | tenofovir disoproxil fumarate | TABLET;ORAL | 078800 | ANDA | Cipla USA Inc. | 69097-533 | 69097-533-15 | 1000 TABLET in 1 BOTTLE (69097-533-15) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
| Approval Date: | Jan 26, 2018 | TE: | AB | RLD: | No | ||||
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