NDA 20227, held by Pharmacia And Upjohn. Ardeparin Sodium.
As of Nov 14, 2026, NDA 20227 (Normiflo), held by Pharmacia And Upjohn, was not approved, with 0 approved supplements and 0 published complete response letters.
| Normiflo10,000 UNITS/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Ardeparin Sodium | DiscontinuedReference drug |
| Normiflo5,000 UNITS/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Ardeparin Sodium | DiscontinuedReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
