Application 009175
- Type
- NDA
- Sponsor
- CASPER PHARMA LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FURADANTIN | NITROFURANTOIN | SUSPENSION;ORAL | 25MG/5ML | Yes | Yes |
| 002 | FURADANTIN | NITROFURANTOIN | SUSPENSION;ORAL | 50MG/5ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16571-740 | Nitrofurantoin | Nitrofurantoin | Rising Pharma Holdings, Inc. | NDA AUTHORIZED GENERIC | Current |
| 16571-740 | Nitrofurantoin | Nitrofurantoin | Rising Pharma Holdings, Inc. | NDA AUTHORIZED GENERIC | Current |
| 59630-450 | Furadantin | nitrofurantoin | Shionogi Inc. | NDA | Current |
| 70199-006 | Furadantin | Nitrofurantoin | Casper Pharma LLC | NDA | Current |
| 70199-006 | Furadantin | Nitrofurantoin | Casper Pharma LLC | NDA | Current |
| 70199-006 | Furadantin | Nitrofurantoin | Casper Pharma LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 77388 | SUPPL | 2024-03-04 |
| 77383 | SUPPL | 2024-02-02 |
| 75516 | SUPPL | 2023-09-20 |
| 75513 | SUPPL | 2023-09-19 |
| 65926 | SUPPL | 2021-01-19 |
| 65925 | SUPPL | 2021-01-19 |
| 59040 | SUPPL | 2019-06-12 |
| 59018 | SUPPL | 2019-06-12 |
| 32991 | SUPPL | 2016-03-18 |
| 11868 | SUPPL | 2013-11-07 |
| 32989 | SUPPL | 2013-11-04 |
| 131 | SUPPL | 2010-11-02 |
| 132 | SUPPL | 2010-10-19 |
| 130 | SUPPL | 2009-02-13 |
| 32990 | SUPPL | 2009-02-10 |
| 11867 | SUPPL | 2008-06-03 |
| 20018 | SUPPL | 2006-05-10 |