Notice2022-16077
Ivax Pharmaceuticals, Inc.; Withdrawal of Approval of an Abbreviated New Drug Application for Chloramphenicol Capsules, 250 Milligrams
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 27, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is withdrawing the approval of abbreviated new drug application (ANDA) 062247 for chloramphenicol capsules, 250 milligrams (mg), held by Ivax Pharmaceuticals, Inc. (Ivax). Ivax requested withdrawal of this application and has waived its opportunity for a hearing.
Indexed from Federal Register on July 27, 2022.
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