Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline Hydrochloride Injection
other · US Department of Health and Human Services · Rule · Published 1997-03-26 · Effective 1997-03-26 · 62 FR 14302
Document
Document number
97-7542
Federal Register citation
62 FR 14302
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
US Department of Health and Human Services
Publication date
1997-03-26
Effective date
1997-03-26
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 Boehringer Ingelheim Animal Health, Inc. The supplemental NADA provides for the subcutaneous use (in addition to the approved intravenous and intramuscular use) of 100 milligrams/ milliliter (mg/mL) of oxytetracycline hydrochloride injection in cattle for the treatment of diseases caused by oxytetracycline susceptible organisms, for a 2-day withdrawal period following the subcutaneous use, and for a 13-day withdrawal period following the intramuscular and intravenous use.