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FEDERAL REGISTER · NOTICEAugust 8, 2024NOTICE — NO LEGAL EFFECT

Determination That CIPRO (Ciprofloxacin Hydrochloride) Tablet, Equivalent to 100 Milligrams Base, Was Withdrawn From Sale for Reasons of Safety or Effectiveness

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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.

STATUSNOTICE — NO LEGAL EFFECT
EFFECTIVE—
COMMENTS CLOSE—
APPLIES TO · SPEQ TAGDrug
Document type
Notice
Agency
Health and Human Services Department
Published
August 8, 2024
Document number
2024-17650
Docket
FDA-2024-N-3510
ABSTRACT

The Food and Drug Administration (FDA or Agency) has determined that CIPRO (ciprofloxacin hydrochloride (HCl)) tablet, equivalent to (EQ) 100 milligrams (mg) base, was withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for ciprofloxacin HCl tablet, EQ 100 mg base.

Abstract as published in the Federal Register.

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The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.

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