FDA — authorised 26 October 1984
- Application: NDA018983
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: COLYTE WITH FLAVOR PACKS
- Indication: FOR SOLUTION — ORAL
- Status: approved
🇺🇸 Nu-Lytely in United States
FDA authorised Nu-Lytely on 26 October 1984
Marketing authorisations
FDA — authorised 30 April 1986
- Application: NDA019284
- Marketing authorisation holder: HOSPIRA
- Local brand name: OCL
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 20 April 1988
- Application: ANDA071320
- Marketing authorisation holder: DYNAPHARM
- Local brand name: COLOVAGE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 5 February 2004
- Application: ANDA076491
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Local brand name: TRILYTE
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 4 May 2006
- Application: ANDA077445
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: POLYETHYLENE GLYCOL 3350
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 26 May 2006
- Application: ANDA077736
- Marketing authorisation holder: BRECKENRIDGE PHARM
- Local brand name: POLYETHYLENE GLYCOL 3350
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 27 September 2006
- Application: ANDA077706
- Marketing authorisation holder: NEXGEN PHARMA INC
- Local brand name: POLYETHYLENE GLYCOL 3350
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 1 June 2009
- Application: ANDA090186
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: PEG 3350 AND ELECTROLYTES
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 1 June 2009
- Application: ANDA090231
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: PEG 3350 AND ELECTROLYTES
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 6 October 2009
- Application: ANDA078915
- Marketing authorisation holder: MYLAN
- Local brand name: POLYETHYLENE GLYCOL 3350
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 6 October 2009
- Application: ANDA090600
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: GLYCOLAX
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 7 October 2009
- Application: ANDA090812
- Marketing authorisation holder: ALLIED
- Local brand name: POLYETHYLENE GLYCOL 3350
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 15 October 2009
- Application: ANDA090567
- Marketing authorisation holder: PADDOCK LLC
- Local brand name: POLYETHYLENE GLYCOL 3350
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 28 January 2010
- Application: ANDA090928
- Marketing authorisation holder: EXTROVIS
- Local brand name: PEG 3350 AND ELECTROLYTES
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 25 February 2010
- Application: ANDA079232
- Marketing authorisation holder: L PERRIGO CO
- Local brand name: LAX-LYTE WITH FLAVOR PACKS
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 7 June 2010
- Application: ANDA090769
- Marketing authorisation holder: PADDOCK LLC
- Local brand name: CLENZ-LYTE
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 31 January 2013
- Application: ANDA079214
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: POLYETHYLENE GLYCOL 3350
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 15 December 2015
- Application: ANDA202850
- Marketing authorisation holder: ANI PHARMS
- Local brand name: POLYETHYLENE GLYCOL 3350
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 24 August 2016
- Application: ANDA203928
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: POLYETHYLENE GLYCOL 3350
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 9 April 2018
- Application: ANDA209017
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: POLYETHYLENE GLYCOL 3350
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA090197
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE; BISACODYL
- Indication: SOLUTION; ORAL AND TABLET; DELAYED RELEASE
- Status: approved
FDA
- Application: ANDA071278
- Marketing authorisation holder: E Z EM
- Local brand name: E-Z-EM PREP LYTE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
Nu-Lytely in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Nu-Lytely approved in United States?
Yes. FDA authorised it on 26 October 1984; FDA authorised it on 30 April 1986; FDA authorised it on 20 April 1988.
Who is the marketing authorisation holder for Nu-Lytely in United States?
STRIDES PHARMA INTL holds the US marketing authorisation.