Details for New Drug Application (NDA): 204519
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NDA 204519 describes CELECOXIB, which is a drug marketed by Alembic, Amneal Pharms, Apotex, Aurobindo Pharma, Cadila Pharms Ltd, Cipla, Cspc Ouyi, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Micro Labs, Nanjing, Pangea, Pharmobedient, Qingdao Baheal Pharm, Sciegen Pharms Inc, Strides Pharma, Teva, Tianjin Tianyao, Torrent, Umedica, Unichem, Watson Labs Inc, Yabao Pharm, Yiling, and Zydus Pharms, and is included in twenty-six NDAs. It is available from sixty-one suppliers. Additional details are available on the CELECOXIB profile page.
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.
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 | Alembic Pharmaceuticals Limited | 46708-267 | 46708-267-12 | 80 CAPSULE in 1 CARTON (46708-267-12) |
| CELECOXIB | celecoxib | CAPSULE;ORAL | 204519 | ANDA | Alembic Pharmaceuticals Limited | 46708-267 | 46708-267-30 | 30 CAPSULE in 1 BOTTLE (46708-267-30) |
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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