Details for New Drug Application (NDA): 211412
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The generic ingredient in CELECOXIB is celecoxib. There are twenty-six drug master file entries for this compound. Sixty-three suppliers are listed for this compound. Additional details are available on the celecoxib profile page.
Summary for 211412
Tradename: | CELECOXIB |
Applicant: | Yiling |
Ingredient: | celecoxib |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 211412
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 211412
Suppliers and Packaging for NDA: 211412
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CELECOXIB | celecoxib | CAPSULE;ORAL | 211412 | ANDA | Chartwell RX, LLC | 62135-021 | 62135-021-60 | 60 CAPSULE in 1 BOTTLE (62135-021-60) |
CELECOXIB | celecoxib | CAPSULE;ORAL | 211412 | ANDA | Chartwell RX, LLC | 62135-022 | 62135-022-01 | 100 CAPSULE in 1 BOTTLE (62135-022-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
Approval Date: | Mar 6, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
Approval Date: | Mar 6, 2020 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 200MG | ||||
Approval Date: | Mar 6, 2020 | TE: | AB | RLD: | No |
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