Application 216145
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ZINC SULFATE | ZINC SULFATE MONOHYDRATE | SOLUTION;INTRAVENOUS | EQ 10MG BASE/10ML (EQ 1MG BASE/ML) | No | No |
| 002 | ZINC SULFATE | ZINC SULFATE MONOHYDRATE | SOLUTION;INTRAVENOUS | EQ 25MG BASE/5ML (EQ 5MG BASE/ML) | No | No |
| 003 | ZINC SULFATE | ZINC SULFATE MONOHYDRATE | SOLUTION;INTRAVENOUS | EQ 30MG BASE/10ML (EQ 3MG BASE/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 65219-401 | Zinc Sulfate | Zinc Sulfate | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-403 | Zinc Sulfate | Zinc Sulfate | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-405 | Zinc Sulfate | Zinc Sulfate | Fresenius Kabi USA, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 73135 | ORIG | 2023-01-10 |