Details for New Drug Application (NDA): 210628
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The generic ingredient in CELECOXIB 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: 210628
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 210628
Suppliers and Packaging for NDA: 210628
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CELECOXIB | celecoxib | CAPSULE;ORAL | 210628 | ANDA | Bryant Ranch Prepack | 71335-2019 | 71335-2019-1 | 30 CAPSULE in 1 BOTTLE (71335-2019-1) |
CELECOXIB | celecoxib | CAPSULE;ORAL | 210628 | ANDA | Bryant Ranch Prepack | 71335-2019 | 71335-2019-2 | 20 CAPSULE in 1 BOTTLE (71335-2019-2) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
Approval Date: | Nov 27, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
Approval Date: | Nov 27, 2019 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 200MG | ||||
Approval Date: | Nov 27, 2019 | TE: | AB | RLD: | No |
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