Regulations.gov document
Exhibit 1- Package Insert for Fresenius Kabi USA’s Atropine Sulfate Injection 8 mg/20 mL…
Supporting & Related Material · FDA-2018-P-2040 · posted May 29, 2018
Key facts
| Document ID | FDA-2018-P-2040-0003 |
|---|---|
| Title | Exhibit 1- Package Insert for Fresenius Kabi USA’s Atropine Sulfate Injection 8 mg/20 mL (0.4 mg/mL) submitted under NDA 209260 (approved January 2018) re: Citizen Petition from Jerry Taylor Reed |
| Document type | Supporting & Related Material |
| Subtype | Background Material |
| Agency | FDA |
| Docket | FDA-2018-P-2040 |
| Posted | May 29, 2018 |
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