Dodex

ANDA 83022, held by Accord Hlthcare. Cyanocobalamin.

As of Nov 15, 2026, ANDA 83022 (Dodex), held by Accord Hlthcare, was first approved by FDA on Sep 20, 1972, with 1 approved supplement and 0 published complete response letters.

First approved: Sep 20, 1972
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Sep 20, 1972	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Dodex1MG/ML · injectable;injection	Cyanocobalamin	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Nov 4, 2024	Supplement 10Manufacturing	Approved	None posted
Sep 20, 1972	Original application	Approved	None posted

Identifiers

Application: ANDA 83022
Drugs@FDA: Overview at FDA
Company: Accord Healthcare

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