Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor; Ferric Oxide Injection; Gleptoferron Injection; Iron Dextran Complex Injection; Iron Hydrogenated Dextran Injection
other · Food and Drug Administration · Rule · Published 2008-03-10 · Effective 2008-03-10 · 73 FR 12634
Document
Document number
E8-4603
Federal Register citation
73 FR 12634
CFR reference
21 CFR 522
Type
Rule
Action
Final rule; technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2008-03-10
Effective date
2008-03-10
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for two new animal drug applications (NADAs) for injectable iron supplements used in baby pigs from Boehringer Ingelheim Vetmedica, Inc., to Animal Health Pharmaceuticals, LLC. In addition, FDA is taking this opportunity to consolidate injectable iron supplements in a single section of the Code of Federal Regulations (CFR). This is being done to simplify and clarify the regulations.