Application 206485
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | MAGNESIUM SULFATE | INJECTABLE;INJECTION | 4GM/100ML (40MG/ML) | No | No |
| 002 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | MAGNESIUM SULFATE | INJECTABLE;INJECTION | 4GM/50ML (80MG/ML) | No | No |
| 003 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | MAGNESIUM SULFATE | INJECTABLE;INJECTION | 2GM/50ML (40MG/ML) | No | No |
| 004 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | MAGNESIUM SULFATE | INJECTABLE;INJECTION | 20GM/500ML (40MG/ML) | No | No |
| 005 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | MAGNESIUM SULFATE | INJECTABLE;INJECTION | 40GM/1000ML (40MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50090-3323 | magnesium sulfate | MAGNESIUM SULFATE HEPTAHYDRATE | A-S Medication Solutions | ANDA | Current |
| 51662-1373 | MAGNESIUM SULFATE | MAGNESIUM SULFATE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1373 | MAGNESIUM SULFATE | MAGNESIUM SULFATE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1373 | MAGNESIUM SULFATE | MAGNESIUM SULFATE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 63323-106 | magnesium sulfate | MAGNESIUM SULFATE HEPTAHYDRATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-106 | magnesium sulfate | MAGNESIUM SULFATE HEPTAHYDRATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-106 | magnesium sulfate | MAGNESIUM SULFATE HEPTAHYDRATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-106 | magnesium sulfate | MAGNESIUM SULFATE HEPTAHYDRATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-106 | magnesium sulfate | MAGNESIUM SULFATE HEPTAHYDRATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-106 | magnesium sulfate | MAGNESIUM SULFATE HEPTAHYDRATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-106 | magnesium sulfate | MAGNESIUM SULFATE HEPTAHYDRATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-107 | magnesium sulfate | MAGNESIUM SULFATE HEPTAHYDRATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-107 | magnesium sulfate | MAGNESIUM SULFATE HEPTAHYDRATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-107 | magnesium sulfate | MAGNESIUM SULFATE HEPTAHYDRATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-107 | magnesium sulfate | MAGNESIUM SULFATE HEPTAHYDRATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 66298-1060 | Magnesium Sulfate | MAGNESIUM SULFATE HEPTAHYDRATE | Fresenius Kabi Norge AS | ANDA | Current |
| 66298-1070 | Magnesium Sulfate | MAGNESIUM SULFATE HEPTAHYDRATE | Fresenius Kabi Norge AS | ANDA | Current |