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GUIDANCE DOCUMENT

Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron Guidance for Industry July 1997

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-1997-D-0489
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance describes how manufacturers and packagers affected by the final rule that published in the Federal Register (62 FR 2218) on January 15, 1997, requiring label warning statements and unit-dose packaging for solid oral drug products that contain 30 milligrams (mg) or more of iron per dosage unit, may meet stability and expiration dating requirements.

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All written comments should be identified with this document's docket number: FDA-1997-D-0489.

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