FDA — authorised 27 May 2009
- Application: ANDA090019
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE
- Indication: FOR SOLUTION — ORAL
- Status: approved
🇺🇸 Cool prep in United States
FDA authorised Cool prep on 27 May 2009
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
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
FDA — authorised 13 April 2015
- Application: ANDA204559
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE
- Indication: FOR SOLUTION — ORAL
- Status: approved
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
Other Gastroenterology approved in United States
Frequently asked questions
Is Cool prep approved in United States?
Yes. FDA authorised it on 27 May 2009; FDA authorised it on 25 January 2012; FDA authorised it on 20 August 2014.
Who is the marketing authorisation holder for Cool prep in United States?
NOVEL LABS INC holds the US marketing authorisation.