← FDA DRUG APPROVALS

FDA NDA · NDA021642

NASCOBAL

cyanocobalamin

Sponsor: ENDO OPERATIONS

APPLICATION
NDA021642
TYPE
NDA
ORIGINAL APPROVAL
2005-01-31
LATEST ACTION
2018-12-07
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Discontinued

Products

NASCOBAL · ReferenceDiscontinued
CYANOCOBALAMIN 0.5MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SPRAY, METERED · NASAL

Approval history

2018-12-07Labeling · Supplement 19 · standard — Label ↗AP
2016-04-25Manufacturing (CMC) · Supplement 24 · standardAP
2015-06-17Manufacturing (CMC) · Supplement 23 · standardAP
2014-10-30Manufacturing (CMC) · Supplement 22 · standardAP
2014-06-11Labeling · Supplement 11 · standardAP
2014-06-06UNKNOWN · Supplement 20 · standard — Review ↗AP
2013-09-06Manufacturing (CMC) · Supplement 21 · standardAP
2012-11-15Manufacturing (CMC) · Supplement 18 · standardAP
2011-12-08Manufacturing (CMC) · Supplement 15 · standard — Letter ↗AP
2006-09-15Labeling · Supplement 2 · standard — Letter ↗AP
2005-01-31Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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