Details for New Drug Application (NDA): 021567
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NDA 021567 describes REYATAZ, which is a drug marketed by Bristol Myers Squibb and is included in two NDAs. It is available from one supplier. Additional details are available on the REYATAZ profile page.
The generic ingredient in REYATAZ is atazanavir sulfate. There are twenty-five drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the atazanavir sulfate profile page.
The generic ingredient in REYATAZ is atazanavir sulfate. There are twenty-five drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the atazanavir sulfate profile page.
Summary for 021567
| Tradename: | REYATAZ |
| Applicant: | Bristol Myers Squibb |
| Ingredient: | atazanavir sulfate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 021567
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| REYATAZ | atazanavir sulfate | CAPSULE;ORAL | 021567 | NDA | E.R. Squibb & Sons, L.L.C. | 0003-3622 | 0003-3622-12 | 30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0003-3622-12) |
| REYATAZ | atazanavir sulfate | CAPSULE;ORAL | 021567 | NDA | E.R. Squibb & Sons, L.L.C. | 0003-3631 | 0003-3631-12 | 60 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0003-3631-12) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jun 20, 2003 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jun 20, 2003 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 200MG BASE | ||||
| Approval Date: | Jun 20, 2003 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 021567
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bristol Myers Squibb | REYATAZ | atazanavir sulfate | CAPSULE;ORAL | 021567-003 | Jun 20, 2003 | 5,849,911*PED | ⤷ Subscribe |
| Bristol Myers Squibb | REYATAZ | atazanavir sulfate | CAPSULE;ORAL | 021567-001 | Jun 20, 2003 | 5,849,911*PED | ⤷ Subscribe |
| Bristol Myers Squibb | REYATAZ | atazanavir sulfate | CAPSULE;ORAL | 021567-004 | Oct 16, 2006 | 5,849,911*PED | ⤷ Subscribe |
| Bristol Myers Squibb | REYATAZ | atazanavir sulfate | CAPSULE;ORAL | 021567-003 | Jun 20, 2003 | 6,087,383*PED | ⤷ Subscribe |
| Bristol Myers Squibb | REYATAZ | atazanavir sulfate | CAPSULE;ORAL | 021567-002 | Jun 20, 2003 | 6,087,383*PED | ⤷ Subscribe |
| Bristol Myers Squibb | REYATAZ | atazanavir sulfate | CAPSULE;ORAL | 021567-002 | Jun 20, 2003 | 5,849,911*PED | ⤷ Subscribe |
| Bristol Myers Squibb | REYATAZ | atazanavir sulfate | CAPSULE;ORAL | 021567-001 | Jun 20, 2003 | 6,087,383*PED | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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