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Details for New Drug Application (NDA): 021548
NDA 021548 describes LEXIVA, which is a drug marketed by Viiv Hlthcare and is included in two NDAs. It is available from four suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the LEXIVA profile page.
The generic ingredient in LEXIVA is fosamprenavir calcium. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the fosamprenavir calcium profile page.
The generic ingredient in LEXIVA is fosamprenavir calcium. There are four drug master file entries for this compound. Five 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: | 2 |
| Therapeutic Class: | Antivirals |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 021548
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEXIVA | fosamprenavir calcium | TABLET;ORAL | 021548 | NDA | REMEDYREPACK INC. | 49349-811 | N | 49349-811-02 |
| LEXIVA | fosamprenavir calcium | TABLET;ORAL | 021548 | NDA | ViiV Healthcare Company | 49702-207 | N | 49702-207-18 |
Profile for product number 001
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