Details for New Drug Application (NDA): 021356
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NDA 021356 describes VIREAD, which is a drug marketed by Gilead Sciences Inc and is included in two NDAs. It is available from one supplier. Additional details are available on the VIREAD profile page.
The generic ingredient in VIREAD is tenofovir disoproxil fumarate. There are forty-two drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the tenofovir disoproxil fumarate profile page.
The generic ingredient in VIREAD is tenofovir disoproxil fumarate. There are forty-two drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the tenofovir disoproxil fumarate profile page.
Summary for 021356
| Tradename: | VIREAD |
| Applicant: | Gilead Sciences Inc |
| Ingredient: | tenofovir disoproxil fumarate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 021356
| Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 021356
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356 | NDA | Gilead Sciences, Inc. | 61958-0401 | 61958-0401-1 | 30 TABLET, COATED in 1 BOTTLE, PLASTIC (61958-0401-1) |
| VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356 | NDA | Gilead Sciences, Inc. | 61958-0404 | 61958-0404-1 | 30 TABLET, COATED in 1 BOTTLE, PLASTIC (61958-0404-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
| Approval Date: | Oct 26, 2001 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
| Approval Date: | Jan 18, 2012 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Jan 18, 2012 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 021356
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356-002 | Jan 18, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
| Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356-002 | Jan 18, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
| Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356-001 | Oct 26, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
| Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356-003 | Jan 18, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
| Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356-002 | Jan 18, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
| Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356-004 | Jan 18, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
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