Details for New Drug Application (NDA): 204519
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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: 204519
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 204519
Suppliers and Packaging for NDA: 204519
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CELECOXIB | celecoxib | CAPSULE;ORAL | 204519 | ANDA | medsource pharmaceuticals | 45865-943 | 45865-943-30 | 30 CAPSULE in 1 BOTTLE (45865-943-30) |
CELECOXIB | celecoxib | CAPSULE;ORAL | 204519 | ANDA | Alembic Pharmaceuticals Limited | 46708-267 | 46708-267-10 | 100 CAPSULE in 1 CARTON (46708-267-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
Approval Date: | Aug 21, 2015 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
Approval Date: | Aug 21, 2015 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 200MG | ||||
Approval Date: | Aug 21, 2015 | TE: | AB | RLD: | No |
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