Orphenadrine Citrate

Relieves discomfort associated with acute painful musculoskeletal conditions. ANDA 40463, held by Hikma. Orphenadrine Citrate.

As of Nov 15, 2026, ANDA 40463 (Orphenadrine Citrate), held by Hikma, was first approved by FDA on Mar 4, 2003, with 2 approved supplements and 0 published complete response letters.

First approved: Mar 4, 2003
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Orphenadrine citrate is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Mar 4, 2003	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Orphenadrine Citrate30MG/ML · injectable;injection	Orphenadrine Citrate	Rx

All 3 submissions, including labeling and manufacturing supplements


Jul 23, 2019	Supplement 10Manufacturing	Approved	None posted
Aug 11, 2008	Supplement 5Labeling	Approved	None posted
Mar 4, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 40463
Drugs@FDA: Overview at FDA
Company: Hikma

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