Details for New Drug Application (NDA): 020998
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NDA 020998 describes CELEBREX, which is a drug marketed by Upjohn and is included in one NDA. It is available from one supplier. 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. Sixty-five 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. Sixty-five suppliers are listed for this compound. Additional details are available on the celecoxib profile page.
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 | Viatris Specialty LLC | 58151-082 | 58151-082-91 | 60 CAPSULE in 1 BOTTLE (58151-082-91) |
| CELEBREX | celecoxib | CAPSULE;ORAL | 020998 | NDA | Viatris Specialty LLC | 58151-083 | 58151-083-01 | 100 CAPSULE in 1 BOTTLE (58151-083-01) |
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 | ||||
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