Digoxin Products for Oral Use; Revocation of Conditions for Marketing
fda-drug · Food and Drug Administration · Rule · Published 2002-06-26 · Effective 2002-07-26 · 67 FR 42992
Document
Document number
02-16108
Federal Register citation
67 FR 42992
CFR reference
21 CFR 310
Type
Rule
Action
Final rule.
Category
fda-drug
Sub-agency
Food and Drug Administration
Publication date
2002-06-26
Effective date
2002-07-26
HHS docket
Docket Nos. 76N-0080 and 00N-1610
Abstract
The Food and Drug Administration (FDA) is revoking the regulation establishing conditions for marketing digoxin products for oral use. This regulation is no longer necessary because the products, which are new drugs, can be regulated under the approval process for new drug applications (NDAs) and abbreviated new drug applications (ANDAs) as set forth in the Federal Food, Drug, and Cosmetic Act (the act).