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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER:206317Orig1s000 MICROBIOLOGY / VIROLOGY REVIEW(S)Product Quality Microbiology Review 01 DEC 2014NDA:206317Drug Product Name Proprietary: Nonproprietary:Traffic Soluble
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Who needs soluble ferric pyrophosphate?

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Soluble ferric pyrophosphate is often needed by individuals who are iron deficient or have certain medical conditions that require iron supplementation.
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Soluble ferric pyrophosphate is a food additive used as an iron source in various food products.
Manufacturers or distributors of food products containing soluble ferric pyrophosphate may be required to file information about its use.
The form for reporting soluble ferric pyrophosphate usage may vary depending on regulatory requirements, but generally, information such as usage levels and purpose of use must be provided.
Soluble ferric pyrophosphate is used to fortify food products with iron, addressing nutritional deficiencies.
Information such as usage levels, product types, and intended purpose of the additive must be reported.
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