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Rulemaking History for OTC Benign Prostatic Hypertrophy Drug Products
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Final Monographs (21 CFR 310.532):  
Drug products containing active ingredients offered over-the-counter (OTC) to relieve the symptoms of benign prostatic hypertrophy

Date Federal Register Citation Description

10/1/1982

47FR43566 PDF document

Advance Notice of Proposed Rulemaking

2/20/1987

52FR5406 PDF document

Tentative Final Monograph

4/14/1987

52FR12114 PDF document

Correction: Tentative Final Monograph

4/30/1987

52FR15732 PDF document

Correction: Tentative Final Monograph

2/27/1990

55FR6926 PDF document

Final Monograph: No GRASE active ingredients

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Date updated: May 9, 2007

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