Relieves discomfort associated with acute painful musculo skeletal conditions. ANDA 40327, held by Sandoz. Orphenadrine Citrate.
As of Nov 15, 2026, ANDA 40327 (Orphenadrine Citrate), held by Sandoz, was first approved by FDA on Feb 15, 2000, with 4 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Orphenadrine citrate extended-release tablets are indicated as an adjunct to rest, physical therapy and other measures for the relief of discomfort associated with acute painful musculo skeletal conditions.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 15, 2000 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Orphenadrine Citrate100MG · tablet, extended release;oral | Orphenadrine Citrate | Rx |
| Mar 30, 2010 | Supplement 12Labeling | Approved | None posted |
| May 8, 2002 | Supplement 3Manufacturing | Approved | None posted |
| May 30, 2001 | Supplement 2Manufacturing | Approved | None posted |
| Feb 15, 2000 | Original application | Approved | |
| Feb 15, 2000 | Supplement 1Manufacturing | Approved | None posted |
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
