Application 201833
- Type
- ANDA
- Sponsor
- WEST-WARD PHARMS INT
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | INJECTABLE;INJECTION | 9MG/ML | No | No |
| 002 | SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | SOLUTION;INJECTION | 90MG/10ML (9MG/ML) | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0641-0497 | Sodium Chloride | Sodium Chloride | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-0497 | Sodium Chloride | Sodium Chloride | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0641-6144 | Sodium Chloride | Sodium Chloride | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6144 | Sodium Chloride | Sodium Chloride | West-Ward Pharmaceuticals Corp. | ANDA | Current |