Application 206171
- Type
- ANDA
- Sponsor
- SPECTRA MDCL DEVICES
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 |
|---|
| 65282-1505 | Sodium Chloride | Sodium Chloride | Spectra Medical Devices, | ANDA | Current |
| 65282-1505 | Sodium Chloride | Sodium Chloride | Spectra Medical Devices, Inc. | ANDA | Current |
| 65282-1505 | Sodium Chloride | Sodium Chloride | Spectra Medical Devices, Inc. | ANDA | Current |
| 65282-1505 | Sodium Chloride | Sodium Chloride | Spectra Medical Devices, Inc. | ANDA | Current |
| 65282-1505 | Sodium Chloride | Sodium Chloride | Spectra Medical Devices, Inc. | ANDA | Current |
| 65282-1505 | Sodium Chloride | Sodium Chloride | Spectra Medical Devices, LLC | ANDA | Current |
| 65282-1505 | Sodium Chloride | Sodium Chloride | Spectra Medical Devices, LLC | ANDA | Current |
| 65282-1510 | Sodium Chloride | Sodium Chloride | Spectra Medical Devices, | ANDA | Current |
| 65282-1510 | Sodium Chloride | Sodium Chloride | Spectra Medical Devices, Inc. | ANDA | Current |
| 65282-1510 | Sodium Chloride | Sodium Chloride | Spectra Medical Devices, Inc. | ANDA | Current |
| 65282-1510 | Sodium Chloride | Sodium Chloride | Spectra Medical Devices, Inc. | ANDA | Current |
| 65282-1510 | Sodium Chloride | Sodium Chloride | Spectra Medical Devices, Inc. | ANDA | Current |
| 65282-1510 | Sodium Chloride | Sodium Chloride | Spectra Medical Devices, LLC | ANDA | Current |
| 65282-1510 | Sodium Chloride | Sodium Chloride | Spectra Medical Devices, LLC | ANDA | Current |