Application 203352
- Type
- ANDA
- Sponsor
- JUBILANT CADISTA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | INJECTABLE;INJECTION | 9MG/ML | No | No |
| 002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | SOLUTION;INJECTION | 27MG/3ML (9MG/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 65044-7131 | sodium chloride | sodium chloride | Jubilant HollisterStier LLC | ANDA | Current |
| 65044-7131 | sodium chloride | sodium chloride | Jubilant HollisterStier LLC | ANDA | Current |
| 65044-7133 | sodium chloride | sodium chloride | Jubilant HollisterStier LLC | ANDA | Current |
| 65044-7133 | sodium chloride | sodium chloride | Jubilant HollisterStier LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 32415 | ORIG | 2016-05-24 |