Details for New Drug Application (NDA): 072267
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NDA 072267 describes FENOPROFEN CALCIUM, which is a drug marketed by Am Therap, Halsey, Misemer, Par Pharm, Quantum Pharmics, Rising, Warner Chilcott, Watson Labs, Ani Pharms, Dava Pharms Inc, Ivax Sub Teva Pharms, Strides Pharma, Sun Pharm Industries, Usl Pharma, Watson Labs Teva, and Xspire Pharma, and is included in thirty-two NDAs. It is available from four suppliers. Additional details are available on the FENOPROFEN CALCIUM profile page.
The generic ingredient in FENOPROFEN CALCIUM is fenoprofen calcium. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the fenoprofen calcium profile page.
The generic ingredient in FENOPROFEN CALCIUM is fenoprofen calcium. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the fenoprofen calcium profile page.
Summary for 072267
| Tradename: | FENOPROFEN CALCIUM |
| Applicant: | Xspire Pharma |
| Ingredient: | fenoprofen calcium |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 072267
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 072267
Suppliers and Packaging for NDA: 072267
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FENOPROFEN CALCIUM | fenoprofen calcium | TABLET;ORAL | 072267 | ANDA | Xspire Pharma, Llc | 42195-471 | 42195-471-01 | 100 TABLET, FILM COATED in 1 BOTTLE (42195-471-01) |
| FENOPROFEN CALCIUM | fenoprofen calcium | TABLET;ORAL | 072267 | ANDA | Xspire Pharma, LLC | 42195-688 | 42195-688-10 | 100 TABLET, FILM COATED in 1 BOTTLE (42195-688-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 600MG BASE | ||||
| Approval Date: | Aug 17, 1988 | TE: | RLD: | No | |||||
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