Details for New Drug Application (NDA): 212564
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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 212564
Tradename: | CELECOXIB |
Applicant: | Yabao Pharm |
Ingredient: | celecoxib |
Patents: | 0 |
Pharmacology for NDA: 212564
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 212564
Suppliers and Packaging for NDA: 212564
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CELECOXIB | celecoxib | CAPSULE;ORAL | 212564 | ANDA | Yabao Pharmaceutical Co., Ltd. Beijing | 51990-033 | 51990-033-01 | 100 CAPSULE in 1 BOTTLE (51990-033-01) |
CELECOXIB | celecoxib | CAPSULE;ORAL | 212564 | ANDA | Yabao Pharmaceutical Co., Ltd. Beijing | 51990-033 | 51990-033-02 | 500 CAPSULE in 1 BOTTLE (51990-033-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
Approval Date: | Apr 10, 2023 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 200MG | ||||
Approval Date: | Apr 10, 2023 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 400MG | ||||
Approval Date: | Apr 10, 2023 | TE: | RLD: | No |
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