Details for New Drug Application (NDA): 208633
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NDA 208633 describes OXAPROZIN, which is a drug marketed by Actavis Elizabeth, Amneal Pharms Co, Beximco Pharms Usa, Chartwell, Dr Reddys Labs Ltd, Ivax Sub Teva Pharms, Mylan Pharms Inc, Norvium Bioscience, Pangea, 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 208633
| Tradename: | OXAPROZIN |
| Applicant: | Amneal Pharms Co |
| Ingredient: | oxaprozin |
| Patents: | 0 |
Pharmacology for NDA: 208633
| Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 208633
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OXAPROZIN | oxaprozin | TABLET;ORAL | 208633 | ANDA | St Mary's Medical Park Pharmacy | 60760-092 | 60760-092-14 | 14 TABLET in 1 BOTTLE, PLASTIC (60760-092-14) |
| OXAPROZIN | oxaprozin | TABLET;ORAL | 208633 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1120 | 69238-1120-1 | 100 TABLET in 1 BOTTLE (69238-1120-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
| Approval Date: | May 4, 2017 | TE: | AB | RLD: | No | ||||
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