Details for New Drug Application (NDA): 075845
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NDA 075845 describes OXAPROZIN, which is a drug marketed by Abraxeolus, Actavis Elizabeth, Amneal Pharms Co, Beximco Pharms Usa, Chartwell, Dr Reddys Labs Ltd, Ivax Sub Teva Pharms, Mylan Pharms Inc, Norvium Bioscience, Sandoz, Sun Pharm Inds Inc, Teva, and Watson Labs, and is included in thirteen NDAs. It is available from eight suppliers. Additional details are available on the OXAPROZIN profile page.
The generic ingredient in OXAPROZIN is oxaprozin. There are thirteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the oxaprozin profile page.
The generic ingredient in OXAPROZIN is oxaprozin. There are thirteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the oxaprozin profile page.
Summary for 075845
| Tradename: | OXAPROZIN |
| Applicant: | Abraxeolus |
| Ingredient: | oxaprozin |
| Patents: | 0 |
Pharmacology for NDA: 075845
| Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 075845
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OXAPROZIN | oxaprozin | TABLET;ORAL | 075845 | ANDA | Eon Labs, Inc. | 0185-0141 | 0185-0141-01 | 100 TABLET in 1 BOTTLE (0185-0141-01) |
| OXAPROZIN | oxaprozin | TABLET;ORAL | 075845 | ANDA | St. Mary's Medical Park Pharmacy | 60760-203 | 60760-203-14 | 14 TABLET in 1 BOTTLE, PLASTIC (60760-203-14) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
| Approval Date: | Jan 31, 2001 | TE: | AB | RLD: | No | ||||
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