Details for New Drug Application (NDA): 214475
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NDA 214475 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, Key Therap, Strides Pharma Intl, Sun Pharm Industries, Usl Pharma, and Watson Labs Teva, 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. Five 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. Five suppliers are listed for this compound. Additional details are available on the fenoprofen calcium profile page.
Summary for 214475
| Tradename: | FENOPROFEN CALCIUM |
| Applicant: | Rising |
| Ingredient: | fenoprofen calcium |
| Patents: | 0 |
Pharmacology for NDA: 214475
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 214475
Suppliers and Packaging for NDA: 214475
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FENOPROFEN CALCIUM | fenoprofen calcium | CAPSULE;ORAL | 214475 | ANDA | Rising Pharma Holdings, Inc. | 16571-688 | 16571-688-09 | 90 CAPSULE in 1 BOTTLE (16571-688-09) |
| FENOPROFEN CALCIUM | fenoprofen calcium | CAPSULE;ORAL | 214475 | ANDA | Rising Pharma Holdings, Inc. | 16571-886 | 16571-886-01 | 100 CAPSULE in 1 BOTTLE (16571-886-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 400MG BASE | ||||
| Approval Date: | Jul 18, 2022 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 200MG BASE | ||||
| Approval Date: | Jul 26, 2024 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 300MG BASE | ||||
| Approval Date: | Jul 26, 2024 | TE: | RLD: | No | |||||
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