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Details for New Drug Application (NDA): 020998
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NDA 020998 describes CELEBREX, which is a drug marketed by Gd Searle and is included in one NDA. It is available from ten suppliers. Additional details are available on the CELEBREX profile page.
The generic ingredient in CELEBREX is celecoxib. There are twenty-six drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the celecoxib profile page.
The generic ingredient in CELEBREX is celecoxib. There are twenty-six drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the celecoxib profile page.
Summary for 020998
| Tradename: | CELEBREX |
| Applicant: | Gd Searle |
| Ingredient: | celecoxib |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 020998
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 020998
Suppliers and Packaging for NDA: 020998
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CELEBREX | celecoxib | CAPSULE;ORAL | 020998 | NDA | G.D. Searle LLC Division of Pfizer Inc | 0025-1515 | 0025-1515-01 | 60 CAPSULE in 1 BOTTLE (0025-1515-01) |
| CELEBREX | celecoxib | CAPSULE;ORAL | 020998 | NDA | G.D. Searle LLC Division of Pfizer Inc | 0025-1520 | 0025-1520-31 | 100 CAPSULE in 1 BOTTLE (0025-1520-31) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
| Approval Date: | Dec 31, 1998 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 200MG | ||||
| Approval Date: | Dec 31, 1998 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 400MG | ||||
| Approval Date: | Aug 29, 2002 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 020998
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Gd Searle | CELEBREX | celecoxib | CAPSULE;ORAL | 020998-003 | Aug 29, 2002 | Start Trial | Start Trial |
| Gd Searle | CELEBREX | celecoxib | CAPSULE;ORAL | 020998-003 | Aug 29, 2002 | Start Trial | Start Trial |
| Gd Searle | CELEBREX | celecoxib | CAPSULE;ORAL | 020998-001 | Dec 31, 1998 | Start Trial | Start Trial |
| Gd Searle | CELEBREX | celecoxib | CAPSULE;ORAL | 020998-003 | Aug 29, 2002 | Start Trial | Start Trial |
| Gd Searle | CELEBREX | celecoxib | CAPSULE;ORAL | 020998-002 | Dec 31, 1998 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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