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FDA CAP 4C0300 – Full Submission & Correspondence, Spirulina Extract (Colorcon)

FDA CAP 4C0300 – Full Submission & Correspondence, Spirulina Extract (Colorcon)

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FDA's full release for Color Additive Petition CAP 4C0300, filed by Colorcon for the use of spirulina extract as a color additive in film coatings for dietary supplement and drug tablet/capsule products.

The 654-page release includes:

  • The original petition and supporting appendices
  • FDA's review correspondence and requests for clarification
  • Colorcon's responses and amendments (2014–2024)

Lightly redacted

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