Implantation or Injectable Dosage Form New Animal Drugs; Hyaluronate Sodium
other · Food and Drug Administration · Rule · Published 1998-11-03 · Effective 1998-11-03 · 63 FR 59215
Document
Document number
98-29332
Federal Register citation
63 FR 59215
CFR reference
21 CFR 510
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1998-11-03
Effective date
1998-11-03
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 Anika Therapeutics, Inc. The supplemental NADA provides for equine use of hyaluronate sodium injection containing 11 milligrams hyaluronate sodium per milliliter (mg/mL) rather than the currently approved 10 mg/mL.