Details for New Drug Application (NDA): 021548
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The generic ingredient in LEXIVA is fosamprenavir calcium. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the fosamprenavir calcium profile page.
Summary for 021548
| Tradename: | LEXIVA |
| Applicant: | Viiv Hlthcare |
| Ingredient: | fosamprenavir calcium |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 700MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Oct 20, 2003 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 021548
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Viiv Hlthcare | LEXIVA | fosamprenavir calcium | TABLET;ORAL | 021548-001 | Oct 20, 2003 | 6,436,989*PED | ⤷ Get Started Free |
| Viiv Hlthcare | LEXIVA | fosamprenavir calcium | TABLET;ORAL | 021548-001 | Oct 20, 2003 | 6,514,953*PED | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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