Application 211091
- Type
- ANDA
- Sponsor
- EXELA PHARMA SCS LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SODIUM BICARBONATE | SODIUM BICARBONATE | INJECTABLE;INJECTION | 0.5MEQ/ML | No | No |
| 002 | SODIUM BICARBONATE | SODIUM BICARBONATE | INJECTABLE;INJECTION | 0.9MEQ/ML | No | No |
| 003 | SODIUM BICARBONATE | SODIUM BICARBONATE | INJECTABLE;INJECTION | 1MEQ/ML | No | No |
| 004 | SODIUM BICARBONATE | SODIUM BICARBONATE | SOLUTION;INTRAVENOUS | 50MEQ/50ML (1MEQ/ML) | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 51754-5001 | Sodium Bicarbonate | SODIUM BICARBONATE | Exela Pharma Sciences, LLC | ANDA | Current |
| 51754-5001 | Sodium Bicarbonate | SODIUM BICARBONATE | Exela Pharma Sciences, LLC | ANDA | Current |
| 51754-5001 | Sodium Bicarbonate | SODIUM BICARBONATE | Exela Pharma Sciences, LLC | ANDA | Current |
| 51754-5002 | Sodium Bicarbonate | SODIUM BICARBONATE | Exela Pharma Sciences, LLC | ANDA | Current |
| 51754-5002 | Sodium Bicarbonate | SODIUM BICARBONATE | Exela Pharma Sciences, LLC | ANDA | Current |
| 51754-5011 | Sodium Bicarbonate | SODIUM BICARBONATE | Exela Pharma Sciences, LLC | ANDA | Current |
| 51754-5011 | Sodium Bicarbonate | SODIUM BICARBONATE | Exela Pharma Sciences, LLC | ANDA | Current |
| 51754-5012 | Sodium Bicarbonate | SODIUM BICARBONATE | Exela Pharma Sciences, LLC | ANDA | Current |
| 51754-5012 | Sodium Bicarbonate | SODIUM BICARBONATE | Exela Pharma Sciences, LLC | ANDA | Current |
| 72572-740 | Sodium Bicarbonate | SODIUM BICARBONATE | Civica | ANDA | Current |