Details for New Drug Application (NDA): 215548
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NDA 215548 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, Pharmaco, Strides Pharma Intl, Sun Pharm Industries, Usl Pharma, and Watson Labs Teva, and is included in thirty-two NDAs. It is available from six suppliers. Additional details are available on the FENOPROFEN CALCIUM profile page.
The generic ingredient in FENOPROFEN CALCIUM is fenoprofen calcium. There is one drug master file entry for this compound. Six 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 is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the fenoprofen calcium profile page.
Summary for 215548
| Tradename: | FENOPROFEN CALCIUM |
| Applicant: | Misemer |
| Ingredient: | fenoprofen calcium |
| Patents: | 0 |
Pharmacology for NDA: 215548
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 215548
Suppliers and Packaging for NDA: 215548
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FENOPROFEN CALCIUM | fenoprofen calcium | CAPSULE;ORAL | 215548 | ANDA | Misemer Pharmaceuticals, Inc. | 0276-0501 | 0276-0501-10 | 100 CAPSULE in 1 BOTTLE (0276-0501-10) |
| FENOPROFEN CALCIUM | fenoprofen calcium | CAPSULE;ORAL | 215548 | ANDA | Misemer Pharmaceuticals, Inc. | 0276-0502 | 0276-0502-10 | 100 CAPSULE in 1 BOTTLE (0276-0502-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 200MG BASE | ||||
| Approval Date: | May 16, 2023 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 300MG BASE | ||||
| Approval Date: | May 16, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 400MG BASE | ||||
| Approval Date: | May 16, 2023 | TE: | RLD: | No | |||||
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