Relieves discomfort associated with acute painful musculoskeletal conditions. ANDA 40284, held by Lupin. Orphenadrine Citrate.
As of Nov 15, 2026, ANDA 40284 (Orphenadrine Citrate), held by Lupin, was first approved by FDA on Jun 19, 1998, with 12 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 musculoskeletal conditions.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 19, 1998 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Orphenadrine Citrate100MG · tablet, extended release;oral | Orphenadrine Citrate | Rx |
| Aug 14, 2024 | Supplement 25Manufacturing | Approved | None posted |
| Jan 28, 2014 | Supplement 21Labeling · Standard review | Approved | None posted |
| Apr 27, 2009 | Supplement 19Labeling | Approved | None posted |
| Oct 8, 2002 | Supplement 11Manufacturing | Approved | None posted |
| Oct 8, 2002 | Supplement 10Manufacturing | Approved | None posted |
| Oct 8, 2002 | Supplement 9Manufacturing | Approved | None posted |
| Oct 8, 2002 | Supplement 8Manufacturing | Approved | None posted |
| Jul 24, 2002 | Supplement 5Manufacturing | Approved | None posted |
| Jul 24, 2002 | Supplement 4Manufacturing | Approved | None posted |
| Mar 22, 2002 | Supplement 7Manufacturing | Approved | None posted |
| Mar 22, 2002 | Supplement 6Manufacturing | Approved | None posted |
| Jun 19, 1998 | Supplement 1Manufacturing | Approved | None posted |
| Jun 19, 1998 | 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
