Details for New Drug Application (NDA): 204590
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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.
Summary for 204590
Tradename: | CELECOXIB |
Applicant: | Macleods Pharms Ltd |
Ingredient: | celecoxib |
Patents: | 0 |
Pharmacology for NDA: 204590
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 204590
Suppliers and Packaging for NDA: 204590
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CELECOXIB | celecoxib | CAPSULE;ORAL | 204590 | ANDA | Macleods Pharmaceuticals Limited | 33342-155 | 33342-155-09 | 60 CAPSULE in 1 BOTTLE (33342-155-09) |
CELECOXIB | celecoxib | CAPSULE;ORAL | 204590 | ANDA | Macleods Pharmaceuticals Limited | 33342-156 | 33342-156-11 | 100 CAPSULE in 1 BOTTLE (33342-156-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
Approval Date: | Mar 16, 2016 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
Approval Date: | Mar 16, 2016 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 200MG | ||||
Approval Date: | Mar 16, 2016 | TE: | AB | RLD: | No |
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