Application 214805
- Type
- ANDA
- Sponsor
- MILLA PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SODIUM ACETATE | SODIUM ACETATE | INJECTABLE;INJECTION | 2MEQ/ML | No | No |
| 002 | SODIUM ACETATE | SODIUM ACETATE | SOLUTION;INTRAVENOUS | 400MEQ/100ML (4MEQ/ML) | No | No |
| 003 | SODIUM ACETATE | SODIUM ACETATE | SOLUTION;INTRAVENOUS | 200MEQ/100ML (2MEQ/ML) | No | No |
| 004 | SODIUM ACETATE | SODIUM ACETATE | SOLUTION;INTRAVENOUS | 40MEQ/20ML (2MEQ/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69784-230 | SODIUM ACETATE | SODIUM ACETATE | Woodward Pharma Services LLC | ANDA | Current |
| 69784-230 | SODIUM ACETATE | SODIUM ACETATE | Woodward Pharma Services LLC | ANDA | Current |
| 69784-231 | SODIUM ACETATE | SODIUM ACETATE | Woodward Pharma Services LLC | ANDA | Current |
| 69784-231 | SODIUM ACETATE | SODIUM ACETATE | Woodward Pharma Services LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 67815 | ORIG | 2021-06-15 |