Nascobal

Treats dietary, drug-induced, or malabsorption-related vitamin B 12 deficiency not due to…. NDA 21642, held by Endo Operations. Cyanocobalamin.

As of Nov 14, 2026, NDA 21642 (Nascobal), held by Endo Operations, was first approved by FDA on Jan 31, 2005, with 10 approved supplements and 0 published complete response letters.

First approved: Jan 31, 2005
Review: Standard
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

NASCOBAL is indicated for: Vitamin B 12 maintenance therapy in adult patients with pernicious anemia who are in remission following intramuscular vitamin B 12 therapy and who have no nervous system involvement Treatment of adult patients with dietary, drug-induced, or malabsorption-related vitamin B 12 deficiency not due to pernicious anemia Prevention of vitamin B 12 deficiency in adult patients with vitamin B 12 requirements in excess of normal Limitations of Use NASCOBAL should not be used for the vitamin B 12 absorption test (Schilling test).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Jan 31, 2005	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Nascobal0.5MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · spray, metered;nasal	Cyanocobalamin	DiscontinuedReference drug

All 11 submissions, including labeling and manufacturing supplements


Dec 7, 2018	Supplement 19Labeling · Standard review	Approved	Letter Label
Apr 25, 2016	Supplement 24Manufacturing · Standard review	Approved	None posted
Jun 17, 2015	Supplement 23Manufacturing · Standard review	Approved	None posted
Oct 30, 2014	Supplement 22Manufacturing · Standard review	Approved	None posted
Jun 11, 2014	Supplement 11Labeling · Standard review	Approved	None posted
Jun 6, 2014	Supplement 20	Approved	Review Label
Sep 6, 2013	Supplement 21Manufacturing · Standard review	Approved	None posted
Nov 15, 2012	Supplement 18Manufacturing · Standard review	Approved	None posted
Dec 8, 2011	Supplement 15Manufacturing · Standard review	Approved	Letter Label
Sep 15, 2006	Supplement 2Labeling · Standard review	Approved	Letter Label
Jan 31, 2005	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 21642
Drugs@FDA: Overview at FDA
Company: Endo Operations

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