Details for New Drug Application (NDA): 021752
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NDA 021752 describes TRUVADA, which is a drug marketed by Gilead and is included in one NDA. It is available from three suppliers. Additional details are available on the TRUVADA profile page.
The generic ingredient in TRUVADA 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 TRUVADA 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 021752
| Tradename: | TRUVADA |
| Applicant: | Gilead |
| Ingredient: | emtricitabine; tenofovir disoproxil fumarate |
| Patents: | 0 |
Pharmacology for NDA: 021752
| Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 021752
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752 | NDA | Gilead Sciences, Inc | 61958-0701 | 61958-0701-1 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0701-1) |
| TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752 | NDA | Gilead Sciences, Inc | 61958-0703 | 61958-0703-1 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0703-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG;300MG | ||||
| Approval Date: | Aug 2, 2004 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG;150MG | ||||
| Approval Date: | Mar 10, 2016 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 133MG;200MG | ||||
| Approval Date: | Mar 10, 2016 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 021752
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Gilead | TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752-004 | Mar 10, 2016 | ⤷ Get Started Free | ⤷ Get Started Free |
| Gilead | TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752-004 | Mar 10, 2016 | ⤷ Get Started Free | ⤷ Get Started Free |
| Gilead | TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752-002 | Mar 10, 2016 | ⤷ Get Started Free | ⤷ Get Started Free |
| Gilead | TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752-004 | Mar 10, 2016 | ⤷ Get Started Free | ⤷ Get Started Free |
| Gilead | TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752-001 | Aug 2, 2004 | ⤷ Get Started Free | ⤷ Get Started Free |
| Gilead | TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752-001 | Aug 2, 2004 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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