ANDA 40484, held by Rising. Orphenadrine Citrate.
As of Nov 15, 2026, ANDA 40484 (Orphenadrine Citrate), held by Rising, was first approved by FDA on May 24, 2006, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 24, 2006 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Orphenadrine Citrate30MG/ML ยท injectable;injection | Orphenadrine Citrate | Rx |
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
