Implantation or Injectable Dosage Form New Animal Drugs; Hemoglobin Glutamer-200 (bovine)
other · Food and Drug Administration · Rule · Published 2000-04-18 · Effective 2000-04-18 · 65 FR 20731
Document
Document number
00-9576
Federal Register citation
65 FR 20731
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2000-04-18
Effective date
2000-04-18
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Biopure Corp. The supplemental NADA provides for flexible dosing for use of hemoglobin glutamer-200 (bovine) to treat anemia in dogs.