Application 018902
- Type
- NDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FUROSEMIDE | FUROSEMIDE | INJECTABLE;INJECTION | 10MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 51662-1572 | FUROSEMIDE | FUROSEMIDE | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 51662-1572 | FUROSEMIDE | FUROSEMIDE | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 51662-1574 | FUROSEMIDE | FUROSEMIDE | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 51662-1574 | FUROSEMIDE | FUROSEMIDE | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 51662-1574 | FUROSEMIDE | FUROSEMIDE | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 51662-1574 | FUROSEMIDE | FUROSEMIDE | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 51662-1575 | FUROSEMIDE | FUROSEMIDE | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 55154-9581 | Furosemide | FUROSEMIDE | Cardinal Health 107, LLC | NDA | Current |
| 55154-9581 | Furosemide | FUROSEMIDE | Cardinal Health | NDA | Current |
| 55154-9582 | Furosemide | FUROSEMIDE | Cardinal Health | NDA | Current |
| 55154-9582 | Furosemide | FUROSEMIDE | Cardinal Health 107, LLC | NDA | Current |
| 63323-280 | Furosemide | FUROSEMIDE | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-280 | Furosemide | FUROSEMIDE | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-280 | Furosemide | FUROSEMIDE | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-280 | Furosemide | FUROSEMIDE | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-280 | Furosemide | FUROSEMIDE | Fresenius Kabi USA, LLC | NDA | Current |
| 81565-201 | Furosemide | FUROSEMIDE | Phlow Corporation | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 79815 | SUPPL | 2024-10-03 |
| 79808 | SUPPL | 2024-10-03 |
| 73606 | SUPPL | 2023-02-24 |
| 73602 | SUPPL | 2023-02-24 |
| 70766 | SUPPL | 2022-04-14 |
| 70757 | SUPPL | 2022-04-13 |
| 45353 | SUPPL | 2016-09-21 |
| 33640 | SUPPL | 2016-03-14 |
| 16087 | SUPPL | 2016-03-10 |