Application 213071
- Type
- ANDA
- Sponsor
- NIVAGEN PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CALCIUM GLUCONATE | CALCIUM GLUCONATE | SOLUTION;INTRAVENOUS | 1GM/10ML (100MG/ML) | No | No |
| 002 | CALCIUM GLUCONATE | CALCIUM GLUCONATE | SOLUTION;INTRAVENOUS | 5GM/50ML (100MG/ML) | No | No |
| 003 | CALCIUM GLUCONATE | CALCIUM GLUCONATE | SOLUTION;INTRAVENOUS | 10GM/100ML (100MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 75834-171 | calcium gluconate | calcium gluconate | Nivagen Pharmaceuticals, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 72946 | ORIG | 2022-12-20 |