ANDA 91158, held by Unichem. Orphenadrine Citrate.
As of Nov 15, 2026, ANDA 91158 (Orphenadrine Citrate), held by Unichem, was first approved by FDA on Jul 27, 2012, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 27, 2012 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Orphenadrine Citrate100MG ยท tablet, extended release;oral | 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
