Relieves discomfort associated with acute painful musculo skeletal conditions. ANDA 90585, held by Sagent Pharms. Orphenadrine Citrate.
As of Nov 15, 2026, ANDA 90585 (Orphenadrine Citrate), held by Sagent Pharms, was first approved by FDA on Aug 30, 2011, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Orphenadrine Citrate Injection is 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 |
|---|---|---|---|
| Aug 30, 2011 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Orphenadrine Citrate30MG/ML · 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
