Application 040572
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | INJECTABLE;INJECTION | EQ 10MG PHOSPHATE/ML | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50090-4567 | Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | A-S Medication Solutions | ANDA | Current |
| 50090-4567 | Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | A-S Medication Solutions | ANDA | Current |
| 51662-1391 | DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1391 | DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 63323-516 | Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-516 | Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-516 | Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-516 | Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-516 | Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Fresenius Kabi USA, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 17785 | SUPPL | 2015-08-17 |
| 7671 | SUPPL | 2015-07-28 |