Determination That Protamine Sulfate (Protamine Sulfate) Intravenous; Solution, 50 Milligr
The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to
| Agency | Health and Human Services Department, Food and Drug Administration |
|---|---|
| Document type | Notice |
| Published | 2026-06-08 |
| Summary | The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. |
| Document number | 2026-11429 |
| Official record | https://www.federalregister.gov/documents/2026/06/08/2026-11429/determination-that-protamine-sulfate-protamine-sulfate-intravenous-solution-50-milligrams5 |