Application 040491
- 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 PRESERVATIVE FREE | 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 |
|---|
| 50090-2363 | Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | A-S Medication Solutions | ANDA | Current |
| 55154-9371 | Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Cardinal Health | ANDA | Current |
| 63187-348 | Dexlido-M Kit | Dexamethasone Sodium Phosphate, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine | Proficient Rx LP | ANDA | Current |
| 63323-506 | Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-506 | Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-506 | Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-506 | Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-506 | Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-506 | Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-506 | Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-506 | Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-506 | Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 69677-071 | MAS CARE-PAK DEXAMETHASONE | Dexamethasone Sodium Phosphate | MAS Management Group Inc. | ANDA | Current |
| 70112-555 | TopiDex | dexamethasone surgical combo kit | Topicare Management, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 7669 | SUPPL | 2015-07-28 |
| 38897 | SUPPL | 2015-07-27 |