Details for New Drug Application (NDA): 090513
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NDA 090513 describes EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, which is a drug marketed by Amneal Pharms Co, Apotex, Aurobindo Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Hetero Labs Ltd Iii, Laurus, Macleods Pharms Ltd, Pharmobedient, Strides Pharma, Teva Pharms Usa, and Zydus Pharms, and is included in thirteen NDAs. It is available from twenty-six suppliers. Additional details are available on the EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE profile page.
The generic ingredient in EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE is emtricitabine; tenofovir disoproxil fumarate. There are eighteen drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the emtricitabine; tenofovir disoproxil fumarate profile page.
The generic ingredient in EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE is emtricitabine; tenofovir disoproxil fumarate. There are eighteen drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the emtricitabine; tenofovir disoproxil fumarate profile page.
Summary for 090513
| Tradename: | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE |
| Applicant: | Aurobindo Pharma |
| Ingredient: | emtricitabine; tenofovir disoproxil fumarate |
| Patents: | 0 |
Pharmacology for NDA: 090513
| Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 090513
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 090513 | ANDA | Aurobindo Pharma Limited | 65862-354 | 65862-354-30 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-354-30) |
| EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 090513 | ANDA | Proficient Rx LP | 71205-776 | 71205-776-03 | 3 TABLET, FILM COATED in 1 BOTTLE (71205-776-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG;300MG | ||||
| Approval Date: | Jan 26, 2018 | TE: | AB | RLD: | No | ||||
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