🇺🇸 CTP0301-A in United States

FDA authorised CTP0301-A on 25 January 2012

Marketing authorisations

FDA — authorised 25 January 2012

  • Application: ANDA090145
  • Marketing authorisation holder: NOVEL LABS INC
  • Local brand name: PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID
  • Indication: FOR SOLUTION — ORAL
  • Status: approved

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FDA — authorised 20 August 2014

  • Application: ANDA202217
  • Marketing authorisation holder: NOVEL LABS INC
  • Local brand name: PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL
  • Indication: FOR SOLUTION, TABLET, DELAYED RELEASE — ORAL
  • Status: approved

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FDA — authorised 28 June 2024

  • Application: ANDA207498
  • Marketing authorisation holder: TARO
  • Local brand name: PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID
  • Indication: FOR SOLUTION — ORAL
  • Status: approved

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Other Diabetes approved in United States

Frequently asked questions

Is CTP0301-A approved in United States?

Yes. FDA authorised it on 25 January 2012; FDA authorised it on 20 August 2014; FDA authorised it on 28 June 2024.

Who is the marketing authorisation holder for CTP0301-A in United States?

NOVEL LABS INC holds the US marketing authorisation.