Details for New Drug Application (NDA): 212689
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NDA 212689 describes EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, which is a drug marketed by Amneal Pharms Co, Apotex, Aurobindo Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Laurus, Macleods Pharms Ltd, Mylan, Strides Pharma, Teva Pharms Usa, and Zydus Pharms, and is included in twelve NDAs. It is available from twenty-eight 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. Thirty-one 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. Thirty-one suppliers are listed for this compound. Additional details are available on the emtricitabine; tenofovir disoproxil fumarate profile page.
Summary for 212689
| Tradename: | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE |
| Applicant: | Zydus Pharms |
| Ingredient: | emtricitabine; tenofovir disoproxil fumarate |
| Patents: | 0 |
Pharmacology for NDA: 212689
| Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 212689
| 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 | 212689 | ANDA | American Health Packaging | 60687-719 | 60687-719-25 | 30 BLISTER PACK in 1 CARTON (60687-719-25) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-719-95) |
| EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 212689 | ANDA | Redpharm Drug, Inc. | 67296-1830 | 67296-1830-7 | 28 TABLET, FILM COATED in 1 BOTTLE (67296-1830-7) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG;300MG | ||||
| Approval Date: | Feb 28, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG;150MG | ||||
| Approval Date: | Jul 1, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 133MG;200MG | ||||
| Approval Date: | Jul 1, 2021 | TE: | AB | RLD: | No | ||||
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