ANDA 40249, held by Rising. Orphenadrine Citrate.
As of Nov 15, 2026, ANDA 40249 (Orphenadrine Citrate), held by Rising, was first approved by FDA on Jan 29, 1999, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 29, 1999 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Orphenadrine Citrate100MG · tablet, extended release;oral | Orphenadrine Citrate | Rx |
| Jun 14, 2024 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jan 29, 1999 | Original application | Approved |
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
