Details for New Drug Application (NDA): 078857
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NDA 078857 describes CELECOXIB, which is a drug marketed by Acic Pharms, Alembic, Amneal Pharms, Apotex, Aurobindo Pharma, Cadila Pharms Ltd, Cipla, Cspc Ouyi, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Micro Labs, Nanjing, Norvium Bioscience, Qingdao Baheal Pharm, Sciegen Pharms Inc, Teva, Tianjin Tianyao, Torrent, Umedica, Unichem, Watson Labs Inc, Yabao Pharm, and Yiling, and is included in twenty-four NDAs. It is available from fifty-nine 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-four 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-four suppliers are listed for this compound. Additional details are available on the celecoxib profile page.
Summary for 078857
| Tradename: | CELECOXIB |
| Applicant: | Norvium Bioscience |
| Ingredient: | celecoxib |
| Patents: | 0 |
Pharmacology for NDA: 078857
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 078857
Suppliers and Packaging for NDA: 078857
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CELECOXIB | celecoxib | CAPSULE;ORAL | 078857 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-257 | 43353-257-30 | 30 CAPSULE in 1 BOTTLE, PLASTIC (43353-257-30) |
| CELECOXIB | celecoxib | CAPSULE;ORAL | 078857 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-257 | 43353-257-53 | 60 CAPSULE in 1 BOTTLE, PLASTIC (43353-257-53) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
| Approval Date: | May 30, 2014 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
| Approval Date: | Feb 11, 2015 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 200MG | ||||
| Approval Date: | Feb 11, 2015 | TE: | RLD: | No | |||||
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