Details for New Drug Application (NDA): 075855
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NDA 075855 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 seven 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. Eleven 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. Eleven suppliers are listed for this compound. Additional details are available on the oxaprozin profile page.
Summary for 075855
| Tradename: | OXAPROZIN |
| Applicant: | Dr Reddys Labs Ltd |
| Ingredient: | oxaprozin |
| Patents: | 0 |
Pharmacology for NDA: 075855
| Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 075855
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OXAPROZIN | oxaprozin | TABLET;ORAL | 075855 | ANDA | Dr. Reddy's Laboratories Limited | 55111-170 | 55111-170-01 | 100 TABLET, FILM COATED in 1 BOTTLE (55111-170-01) |
| OXAPROZIN | oxaprozin | TABLET;ORAL | 075855 | ANDA | Dr. Reddy's Laboratories Limited | 55111-170 | 55111-170-05 | 500 TABLET, FILM COATED in 1 BOTTLE (55111-170-05) |
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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