Application 019887
- Type
- NDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NEBUPENT | PENTAMIDINE ISETHIONATE | FOR SOLUTION;INHALATION | 300MG/VIAL | Yes | Yes |
| 002 | NEBUPENT | PENTAMIDINE ISETHIONATE | FOR SOLUTION;INHALATION | 600MG/VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-877 | NebuPent | PENTAMIDINE ISETHIONATE | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-877 | NebuPent | PENTAMIDINE ISETHIONATE | Fresenius Kabi USA, LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 19794 | SUPPL | 2011-02-14 |
| 34069 | SUPPL | 2011-02-09 |