Application 207449
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE | INJECTABLE;INJECTION | 50MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 17271-720 | Dextrose | Dextrose Monohydrate | Becton Dickinson and Company | ANDA | Current |
| 17271-720 | Dextrose | Dextrose Monohydrate | Becton Dickinson and Company | ANDA | Current |
| 17271-720 | Dextrose | Dextrose Monohydrate | Becton Dickinson and Company | ANDA | Current |
| 63323-624 | Dextrose | Dextrose Monohydrate | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-624 | Dextrose | Dextrose Monohydrate | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-624 | Dextrose | Dextrose Monohydrate | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-234 | Dextrose | Dextrose Monohydrate | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-234 | Dextrose | Dextrose Monohydrate | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-236 | Dextrose | Dextrose Monohydrate | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-236 | Dextrose | Dextrose Monohydrate | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-238 | Dextrose | Dextrose Monohydrate | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-238 | Dextrose | Dextrose Monohydrate | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-240 | Dextrose | Dextrose Monohydrate | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-240 | Dextrose | Dextrose Monohydrate | Fresenius Kabi USA, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 45816 | ORIG | 2016-11-04 |
| 45730 | ORIG | 2016-10-31 |