Orphenadrine Citrate

ANDA 85046, held by Sandoz. Orphenadrine Citrate.

As of Nov 15, 2026, ANDA 85046 (Orphenadrine Citrate), held by Sandoz, was not approved, with 5 approved supplements and 0 published complete response letters.

First approved: Not approved
Supplements approved: 5
Complete response letters: 0

Products

1 strengths and forms

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

All 5 submissions, including labeling and manufacturing supplements


May 17, 1983	Supplement 1Manufacturing	Approved	None posted
Apr 28, 1983	Supplement 8Manufacturing	Approved	None posted
Jan 12, 1983	Supplement 6Manufacturing	Approved	None posted
Jan 12, 1983	Supplement 7Manufacturing	Approved	None posted
Jun 29, 1982	Supplement 4Manufacturing	Approved	None posted

Identifiers

Application: ANDA 85046
Drugs@FDA: Overview at FDA
Company: Sandoz

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