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    Sodium Phenylbutyrate

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    Last Updated on PharmaCompass Virtual Booth Country Holder DMF No. Subject Submission Date Status Type GDUFA DMF Review GDUFA Review Date GDUFA Payment Date
    09/01/2026 HRV Pharma
    India
    		 NEW HORIZON PHARMA US INC 42498 SODIUM PHENYLBUTYRATE USP 2025-09-30 Active II N/A
    30/12/2025 Nuray Chemicals Private Limited
    India
    		 SS PHARMA LLC 38890 SODIUM PHENYLBUTYRATE USP 2023-09-29 Active II Complete 2023-11-15 2023-09-27
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