Details for New Drug Application (NDA): 020998
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The generic ingredient in CELEBREX is celecoxib. There are twenty-six drug master file entries for this compound. Sixty suppliers are listed for this compound. Additional details are available on the celecoxib profile page.
Summary for 020998
Tradename: | CELEBREX |
Applicant: | Upjohn |
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 | Pfizer Laboratories Div Pfizer Inc | 0025-1515 | 0025-1515-01 | 60 CAPSULE in 1 BOTTLE (0025-1515-01) |
CELEBREX | celecoxib | CAPSULE;ORAL | 020998 | NDA | Pfizer Laboratories Div 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 |
---|---|---|---|---|---|---|---|
Upjohn | CELEBREX | celecoxib | CAPSULE;ORAL | 020998-001 | Dec 31, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
Upjohn | CELEBREX | celecoxib | CAPSULE;ORAL | 020998-003 | Aug 29, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Upjohn | CELEBREX | celecoxib | CAPSULE;ORAL | 020998-001 | Dec 31, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
Upjohn | CELEBREX | celecoxib | CAPSULE;ORAL | 020998-004 | Dec 15, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Upjohn | CELEBREX | celecoxib | CAPSULE;ORAL | 020998-004 | Dec 15, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Upjohn | CELEBREX | celecoxib | CAPSULE;ORAL | 020998-001 | Dec 31, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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