Details for New Drug Application (NDA): 201806
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NDA 201806 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-seven 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-nine 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-nine suppliers are listed for this compound. Additional details are available on the emtricitabine; tenofovir disoproxil fumarate profile page.
Summary for 201806
| Tradename: | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE |
| Applicant: | Hetero Labs Ltd Iii |
| Ingredient: | emtricitabine; tenofovir disoproxil fumarate |
| Patents: | 0 |
Pharmacology for NDA: 201806
| Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 201806
| 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 | 201806 | ANDA | Camber Pharmaceuticals, Inc. | 31722-560 | 31722-560-30 | 30 TABLET, FILM COATED in 1 BOTTLE (31722-560-30) |
| EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 201806 | ANDA | A-S Medication Solutions | 50090-7719 | 50090-7719-1 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-7719-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG;300MG | ||||
| Approval Date: | Oct 7, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG;150MG | ||||
| Approval Date: | Mar 3, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 133MG;200MG | ||||
| Approval Date: | Mar 3, 2025 | TE: | AB | RLD: | No | ||||
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