Pharmaceutical Policy
Documents
Final Response
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Relisting Notice Protamine Sulfate (Protamine Sulfate) IV Solution 50mg per mL
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Suitability Petition from Felix Pharmaceuticals Pvt. Ltd.
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Response Letter
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Completeness Assessment Correspondence
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Suitability Petition from Felix Pharmaceuticals Pvt. Ltd.
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Amendment to Suitability Petition from Felix Pharmaceuticals Pvt. Ltd.
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Suitability Petition from Hyman, Phelps, & McNamara P.C.
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Completeness Assessment Correspondence
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Completeness Assessment Correspondence to Apotex Corp.
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Citizen Petition from Windels Marx Lane & Mittendorf, LLP
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Acknowledgement Letter from FDA DMB to Windels Marx Lane & Mittendorf, LLP
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