Cyanocobalamin

ANDA 80573, held by Dr Reddys. Cyanocobalamin.

As of Nov 15, 2026, ANDA 80573 (Cyanocobalamin), held by Dr Reddys, was first approved by FDA on Jan 29, 1974, with 20 approved supplements and 0 published complete response letters.

First approved: Jan 29, 1974
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Jan 29, 1974	Original application	Approved	None posted

Products

2 strengths and forms


Cyanocobalamin1MG/ML · injectable;injection	Cyanocobalamin	Discontinued
Cyanocobalamin0.1MG/ML · injectable;injection	Cyanocobalamin	Discontinued

All 21 submissions, including labeling and manufacturing supplements


Feb 19, 1999	Supplement 627Manufacturing	Approved	None posted
Feb 2, 1999	Supplement 626Manufacturing	Approved	None posted
Dec 4, 1996	Supplement 625Manufacturing	Approved	None posted
Nov 4, 1993	Supplement 624Labeling	Approved	None posted
Nov 12, 1991	Supplement 623Labeling	Approved	None posted
Nov 12, 1991	Supplement 622Manufacturing	Approved	None posted
Nov 12, 1991	Supplement 621Manufacturing	Approved	None posted
Nov 12, 1991	Supplement 620Manufacturing	Approved	None posted
Nov 12, 1991	Supplement 619Manufacturing	Approved	None posted
Apr 15, 1991	Supplement 618Manufacturing	Approved	None posted
Apr 15, 1991	Supplement 617Manufacturing	Approved	None posted
Apr 15, 1991	Supplement 616Manufacturing	Approved	None posted
Nov 3, 1989	Supplement 614Manufacturing	Approved	None posted
Dec 21, 1988	Supplement 613Manufacturing	Approved	None posted
Aug 3, 1988	Supplement 611Manufacturing	Approved	None posted
Aug 3, 1988	Supplement 610Manufacturing	Approved	None posted
Aug 6, 1986	Supplement 608Manufacturing	Approved	None posted
Feb 1, 1985	Supplement 607Manufacturing	Approved	None posted
Feb 16, 1984	Supplement 605Manufacturing	Approved	None posted
Jan 27, 1983	Supplement 604Manufacturing	Approved	None posted
Jan 29, 1974	Original application	Approved	None posted

Identifiers

Application: ANDA 80573
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's 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