Details for New Drug Application (NDA): 075679
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NDA 075679 describes KETOPROFEN, which is a drug marketed by Actavis Labs Fl Inc, Alkermes Gainesville, Mylan, Misemer, Rising, Teva, and Perrigo, and is included in ten NDAs. It is available from five suppliers. Additional details are available on the KETOPROFEN profile page.
The generic ingredient in KETOPROFEN is ketoprofen. There are twenty-seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the ketoprofen profile page.
The generic ingredient in KETOPROFEN is ketoprofen. There are twenty-seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the ketoprofen profile page.
Summary for 075679
| Tradename: | KETOPROFEN |
| Applicant: | Mylan |
| Ingredient: | ketoprofen |
| Patents: | 0 |
Pharmacology for NDA: 075679
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 075679
Suppliers and Packaging for NDA: 075679
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KETOPROFEN | ketoprofen | CAPSULE, EXTENDED RELEASE;ORAL | 075679 | ANDA | Mylan Pharmaceuticals Inc. | 0378-8200 | 0378-8200-01 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-8200-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 200MG | ||||
| Approval Date: | Feb 20, 2002 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 150MG | ||||
| Approval Date: | Feb 20, 2002 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 100MG | ||||
| Approval Date: | Feb 20, 2002 | TE: | RLD: | No | |||||
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