Orphenadrine Citrate

Relieves discomfort associated with acute, painful musculo-skeletal conditions. ANDA 84779, held by Watson Labs. Orphenadrine Citrate.

As of Nov 15, 2026, ANDA 84779 (Orphenadrine Citrate), held by Watson Labs, was first approved by FDA on Mar 15, 1982, with 13 approved supplements and 0 published complete response letters.

First approved: Mar 15, 1982
Supplements approved: 13
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 musculo-skeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its analgesic properties. Orphenadrine citrate does not directly relax tense skeletal muscles in man.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Mar 15, 1982	Original application	Approved	None posted

Products

1 strengths and forms

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

All 14 submissions, including labeling and manufacturing supplements


Apr 16, 2007	Supplement 19Labeling	Approved	None posted
Feb 19, 1999	Supplement 17Manufacturing	Approved	None posted
Feb 2, 1999	Supplement 16Manufacturing	Approved	None posted
Jun 20, 1997	Supplement 15Manufacturing	Approved	None posted
Apr 3, 1996	Supplement 14Manufacturing	Approved	None posted
Aug 16, 1995	Supplement 13Manufacturing	Approved	None posted
Dec 12, 1994	Supplement 12Manufacturing	Approved	None posted
Sep 27, 1990	Supplement 11Labeling	Approved	None posted
Dec 23, 1988	Supplement 6Bioequivalence	Approved	None posted
Nov 18, 1988	Supplement 10Manufacturing	Approved	None posted
Nov 18, 1988	Supplement 9Manufacturing	Approved	None posted
May 28, 1986	Supplement 4Manufacturing	Approved	None posted
Feb 17, 1984	Supplement 1Manufacturing	Approved	None posted
Mar 15, 1982	Original application	Approved	None posted

Identifiers

Application: ANDA 84779
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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