Application 088912
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | INJECTABLE;INJECTION | 9MG/ML | No | Yes |
| 002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | SOLUTION;INJECTION | 180MG/20ML (9MG/ML) | No | Yes |
| 003 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | SOLUTION;INJECTION | 270MG/30ML (9MG/ML) | No | Yes |
| 004 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | SOLUTION;INJECTION | 18MG/2ML (9MG/ML) | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0404-9955 | Sodium Chloride | Sodium Chloride | Henry Schein, Inc. | ANDA | Current |
| 0404-9955 | Sodium Chloride | Sodium Chloride | Henry Schein, Inc. | ANDA | Current |
| 50090-2488 | Sodium Chloride | SODIUM CHLORIDE | A-S Medication Solutions | ANDA | Current |
| 50090-2488 | Sodium Chloride | SODIUM CHLORIDE | A-S Medication Solutions | ANDA | Current |
| 50090-2488 | Sodium Chloride | SODIUM CHLORIDE | A-S Medication Solutions | ANDA | Current |
| 52584-186 | Sodium Chloride | Sodium Chloride | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-186 | Sodium Chloride | Sodium Chloride | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-186 | Sodium Chloride | Sodium Chloride | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-186 | Sodium Chloride | Sodium Chloride | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-186 | Sodium Chloride | Sodium Chloride | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-186 | Sodium Chloride | Sodium Chloride | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-186 | Sodium Chloride | Sodium Chloride | General Injectables and Vaccines, Inc. | ANDA | Current |
| 55154-9357 | Sodium Chloride | SODIUM CHLORIDE | Cardinal Health | ANDA | Current |
| 55154-9357 | Sodium Chloride | SODIUM CHLORIDE | Cardinal Health | ANDA | Current |
| 55154-9357 | Sodium Chloride | SODIUM CHLORIDE | Cardinal Health | ANDA | Current |
| 55154-9357 | Sodium Chloride | SODIUM CHLORIDE | Cardinal Health 107, LLC | ANDA | Current |
| 55154-9357 | Sodium Chloride | SODIUM CHLORIDE | Cardinal Health | ANDA | Current |
| 55154-9357 | Sodium Chloride | SODIUM CHLORIDE | Cardinal Health 107, LLC | ANDA | Current |
| 63323-186 | Sodium Chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-186 | Sodium Chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-186 | Sodium Chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-186 | Sodium Chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 70518-1425 | Sodium Chloride | SODIUM CHLORIDE | REMEDYREPACK INC. | ANDA | Current |