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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 two suppliers. There is one patent 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. Three 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. Three 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: | 1 |
| 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 | ViiV Healthcare Company | 49702-207 | 49702-207-18 | 60 TABLET, FILM COATED in 1 BOTTLE (49702-207-18) |
| LEXIVA | fosamprenavir calcium | TABLET;ORAL | 021548 | NDA | State of Florida DOH Central Pharmacy | 53808-1010 | 53808-1010-1 | 30 TABLET, FILM COATED in 1 BLISTER PACK (53808-1010-1) |
Paragraph IV (Patent) Challenges for 021548
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| LEXIVA | TABLET;ORAL | fosamprenavir calcium | 021548 | 2012-01-18 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 700MG BASE | ||||
| Approval Date: | Oct 20, 2003 | TE: | AB | RLD: | Yes | ||||
| Patent: | Start Trial | Patent Expiration: | Jan 15, 2020 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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