Application 214475
- Type
- ANDA
- Sponsor
- RISING
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FENOPROFEN CALCIUM | FENOPROFEN CALCIUM | CAPSULE;ORAL | EQ 400MG BASE | No | No |
| 002 | FENOPROFEN CALCIUM | FENOPROFEN CALCIUM | CAPSULE;ORAL | EQ 200MG BASE | No | No |
| 003 | FENOPROFEN CALCIUM | FENOPROFEN CALCIUM | CAPSULE;ORAL | EQ 300MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16571-688 | FENOPROFEN CALCIUM | FENOPROFEN CALCIUM | Rising Pharma Holdings, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 71960 | ORIG | 2022-08-30 |