Hydroxocobalamin

Treats neoplasia. ANDA 85998, held by Actavis. Hydroxocobalamin.

As of Nov 13, 2026, ANDA 85998 (Hydroxocobalamin), held by Actavis, was first approved by FDA on Aug 16, 1978, with 23 approved supplements and 0 published complete response letters.

First approved: Aug 16, 1978
Supplements approved: 23
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Pernicious anemia, both uncomplicated and accompanied by nervous system involvement. Dietary deficiency of Vitamin B 12, occurring in strict vegetarians and in their breast-fed infants. (Isolated vitamin B 12 deficiency is very rare). Malabsorption of vitamin B 12, resulting from structural or functional damage to the stomach, where intrinsic factor is secreted or to the ileum, where intrinsic factor facilitates vitamin B 12 absorption. These conditions include tropical sprue, and nontropical sprue (idiopathic steatorrhea, gluten-induced enteropathy). Folate deficiency in these patients is usually more severe than vitamin B 12 deficiency.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below

Date	Submission	Status	Documents
Aug 16, 1978	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydroxocobalamin1MG/ML · injectable;injection	Hydroxocobalamin	Rx

All 24 submissions, including labeling and manufacturing supplements


Jul 8, 2002	Supplement 91Manufacturing	Approved	None posted
Jun 6, 2002	Supplement 89Manufacturing	Approved	None posted
Feb 12, 2002	Supplement 86Manufacturing	Approved	None posted
Jul 18, 2001	Supplement 90Manufacturing	Approved	None posted
May 4, 2001	Supplement 87Manufacturing	Approved	None posted
May 4, 2001	Supplement 88Manufacturing	Approved	None posted
Sep 15, 2000	Supplement 85Manufacturing	Approved	None posted
Aug 18, 2000	Supplement 83Manufacturing	Approved	None posted
Jun 29, 2000	Supplement 84Manufacturing	Approved	None posted
May 25, 2000	Supplement 81Manufacturing	Approved	None posted
Nov 22, 1999	Supplement 79Manufacturing	Approved	None posted
Nov 22, 1999	Supplement 80Labeling	Approved	None posted
Mar 4, 1999	Supplement 76Manufacturing	Approved	None posted
Feb 19, 1999	Supplement 77Manufacturing	Approved	None posted
Feb 2, 1999	Supplement 75Manufacturing	Approved	None posted
Oct 29, 1997	Supplement 72Manufacturing	Approved	None posted
Oct 29, 1997	Supplement 74Labeling	Approved	None posted
Dec 4, 1996	Supplement 73Manufacturing	Approved	None posted
Feb 11, 1992	Supplement 71Labeling	Approved	None posted
Feb 11, 1992	Supplement 107Labeling	Approved	None posted
May 9, 1989	Supplement 69Manufacturing	Approved	None posted
May 9, 1989	Supplement 70Manufacturing	Approved	None posted
Aug 7, 1986	Supplement 66Manufacturing	Approved	None posted
Aug 16, 1978	Original application	Approved	None posted

Identifiers

Application: ANDA 85998
Drugs@FDA: Overview at FDA
Company: Actavis

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