Application 207442
- Type
- ANDA
- Sponsor
- SOMERSET THERAPS LLC
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | DEXAMETHASONE SODIUM PHOSPHATE | INJECTABLE;INJECTION | EQ 10MG PHOSPHATE/ML | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 70069-021 | Dexamethasone Sodium Phosphate | Dexamethasone Sodium Phosphate | Somerset Therapeutics, LLC | ANDA | Current |
| 70069-021 | Dexamethasone Sodium Phosphate | Dexamethasone Sodium Phosphate | Somerset Therapeutics, LLC | ANDA | Current |
| 70069-021 | Dexamethasone Sodium Phosphate | Dexamethasone Sodium Phosphate | Somerset Therapeutics, LLC | ANDA | Current |
| 70069-021 | Dexamethasone Sodium Phosphate | Dexamethasone Sodium Phosphate | Somerset Therapeutics, LLC | ANDA | Current |