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Application 018893
- Type
- NDA
- Sponsor
- HOSPIRA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SODIUM ACETATE | SODIUM ACETATE | INJECTABLE;INJECTION | 2MEQ/ML | Yes | Yes |
| 002 | SODIUM ACETATE | SODIUM ACETATE | SOLUTION;INTRAVENOUS | 100MEQ/50ML (2MEQ/ML) | Yes | Yes |
| 003 | SODIUM ACETATE | SODIUM ACETATE | SOLUTION;INTRAVENOUS | 200MEQ/100ML (2MEQ/ML) | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0409-3299 | Sodium Acetate | sodium acetate | Hospira, Inc. | NDA | Current |
| 0409-3299 | Sodium Acetate | sodium acetate | Hospira, Inc. | NDA | Current |
| 0409-3299 | Sodium Acetate | sodium acetate | Hospira, Inc. | NDA | Current |
| 0409-3299 | Sodium Acetate | sodium acetate | Hospira, Inc. | NDA | Current |
| 0409-3299 | Sodium Acetate | sodium acetate | Hospira, Inc. | NDA | Current |
| 0409-3299 | Sodium Acetate | sodium acetate | Hospira, Inc. | NDA | Current |
| 0409-7299 | Sodium Acetate | SODIUM ACETATE | Hospira, Inc. | NDA | Current |
| 0409-7299 | Sodium Acetate | SODIUM ACETATE | Hospira, Inc. | NDA | Current |
| 0409-7299 | Sodium Acetate | SODIUM ACETATE | Hospira, Inc. | NDA | Current |
| 0409-7299 | Sodium Acetate | SODIUM ACETATE | Hospira, Inc. | NDA | Current |
| 0409-7299 | Sodium Acetate | SODIUM ACETATE | Hospira, Inc. | NDA | Current |
| 0409-7299 | Sodium Acetate | SODIUM ACETATE | Hospira, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 33637 | SUPPL | 2014-09-03 |
| 1121 | SUPPL | 2003-03-10 |