Orphenadrine Citrate

ANDA 40368, held by Stevens J. Orphenadrine Citrate.

As of Nov 15, 2026, ANDA 40368 (Orphenadrine Citrate), held by Stevens J, was first approved by FDA on Jun 23, 2000, with 3 approved supplements and 0 published complete response letters.

First approved: Jun 23, 2000
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jun 23, 2000	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Orphenadrine Citrate100MG · tablet, extended release;oral	Orphenadrine Citrate	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Jun 29, 2001	Supplement 3Manufacturing	Approved	None posted
Jun 29, 2001	Supplement 2Manufacturing	Approved	None posted
Jan 25, 2001	Supplement 1Manufacturing	Approved	None posted
Jun 23, 2000	Original application	Approved	Letter

Identifiers

Application: ANDA 40368
Drugs@FDA: Overview at FDA
Company: Stevens J

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