01 2Aspen Pharmacare Holdings
02 2Taro Pharmaceutical Industries
03 2Strides Pharma Science
04 1ABC Farmaceutici SpA
05 1Alfasigma
06 1Alkem Laboratories
07 1Annora Pharma
08 1Aralez Pharmaceuticals
09 5BRAINTREE LABS
10 1Bionpharma
11 4CPS Cito Pharma Services GmbH
12 1Dynapharm
13 1E-Z-EM Canada Inc, dba Therapex
14 1GATOR PHARMS
15 2Giuliani
16 1Hospira, Inc.
17 8NORVIUM BIOSCIENCE
18 5Norgine
19 4Novel Laboratories, Inc.
20 1PAI HOLDINGS
21 3PENDOPHARM DIVISION OF DE PHARMASCIENCE INC
22 3PROMEFARM Srl
23 3Perrigo Company plc
24 1Rising Pharmaceuticals Inc
25 2Salix Pharmaceuticals
26 1Sandoz B2B
27 1Spirig Healthcare
28 1Teva API
29 2Vintage Pharmaceuticals-Charlotte
30 1World Medicine
01 20FOR SOLUTION;ORAL
02 6FOR SUSPENSION;ORAL
03 1INJECTABLE
04 1POW
05 3POWDER FOR SOLUTION
06 1POWDER;ORAL
07 9Plv
08 1Plv F?r Trinkl?sung
09 1SAC
10 11SOLUTION;ORAL
11 1TABLET (DELAYED-RELEASE)
12 1TABLET;ORAL
13 7Blank
01 21DISCN
02 4Ethical
03 1Generic
04 2Originator
05 16RX
06 19Blank
01 1BI-PEGLYTE
02 1CLENZ-LYTE
03 1CO-LAV
04 1COLOVAGE
05 1COLPREP KIT
06 6COLYTE
07 1COLYTE WITH FLAVOR PACKS
08 2COLYTE-FLAVORED
09 1Clensia
10 1Cololyt
11 1E-Z-EM PREP LYTE
12 1GLYCOPREP
13 1GO-EVAC
14 2GOLYTELY
15 2Isocolan
16 1Klean Prep
17 1Klean-prep
18 1MAGNESIUM SULFATE ANHYDROUS; POTASSIUM SULFATE; SODIUM SULFATE
19 3MOVIPREP
20 1Moviprep
21 1Moviprep Orange one application
22 1Moviprep eine Anwendung
23 1OCL
24 3PEG 3350 AND ELECTROLYTES
25 2PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID
26 1PEG-LYTE
27 1PEGLYTE POWDER
28 1PLENVU
29 2POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES
30 1Plenvu
31 1Polyethylene Glycol + Salts Sodium/Potassium
32 7SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE
33 1SUCLEAR
34 1SUPREP BOWEL PREP KIT
35 1SUTAB
36 2Selg
37 1Selg They
38 2Transipeg
39 2Transipeg forte
40 1Blank
01 4Canada
02 7Italy
03 2South Africa
04 10Switzerland
05 1Turkey
06 39USA
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : MOVIPREP
Dosage Form : POW
Dosage Strength : 7.5g
Packaging : 1X1g
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
Regulatory Info : RX
Registration Country : USA
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS
Brand Name : POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES
Dosage Form : FOR SOLUTION;ORAL
Dosage Strength : 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT
Packaging :
Approval Date : 2018-12-21
Application Number : 204558
Regulatory Info : RX
Registration Country : USA
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Klean-prep
Dosage Form : SAC
Dosage Strength : 5.685g
Packaging : 4X1g
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : RX
Registration Country : USA
MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE
Brand Name : SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE
Dosage Form : SOLUTION;ORAL
Dosage Strength : 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT
Packaging :
Approval Date : 2024-03-19
Application Number : 206431
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE
Brand Name : PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID
Dosage Form : FOR SOLUTION;ORAL
Dosage Strength : 4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM
Packaging :
Approval Date : 2024-06-28
Application Number : 207498
Regulatory Info : RX
Registration Country : USA
Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
Regulatory Info : RX
Registration Country : USA
MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE
Brand Name : SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE
Dosage Form : SOLUTION;ORAL
Dosage Strength : 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT
Packaging :
Approval Date : 2023-11-22
Application Number : 215469
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS
Brand Name : GOLYTELY
Dosage Form : FOR SOLUTION;ORAL
Dosage Strength : 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT
Packaging :
Approval Date : 1984-07-13
Application Number : 19011
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS
Brand Name : GOLYTELY
Dosage Form : FOR SOLUTION;ORAL
Dosage Strength : 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET
Packaging :
Approval Date : 1992-06-02
Application Number : 19011
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE
Brand Name : SUPREP BOWEL PREP KIT
Dosage Form : SOLUTION;ORAL
Dosage Strength : 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT
Packaging :
Approval Date : 2010-08-05
Application Number : 22372
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS
Brand Name : E-Z-EM PREP LYTE
Dosage Form : FOR SUSPENSION;ORAL
Dosage Strength : 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT
Packaging :
Approval Date : 1988-11-21
Application Number : 71278
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE
Brand Name : OCL
Dosage Form : SOLUTION;ORAL
Dosage Strength : 6GM/100ML;75MG/100ML;168MG/100ML;146MG/100ML;1.29GM/100ML
Packaging :
Approval Date : 1986-04-30
Application Number : 19284
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE
Brand Name : MOVIPREP
Dosage Form : FOR SOLUTION;ORAL
Dosage Strength : 4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM
Packaging :
Approval Date : 2006-08-02
Application Number : 21881
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS
Brand Name : COLYTE
Dosage Form : FOR SOLUTION;ORAL
Dosage Strength : 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 1984-10-26
Application Number : 18983
Regulatory Info : DISCN
Registration Country : USA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : DISCN
Registration Country : USA
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS
Brand Name : COLYTE
Dosage Form : FOR SOLUTION;ORAL
Dosage Strength : 120GM/PACKET;1.49GM/PACKET;3.36GM/PACKET;2.92GM/PACKET;11.36GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 1984-10-26
Application Number : 18983
Regulatory Info : DISCN
Registration Country : USA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : DISCN
Registration Country : USA
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS
Brand Name : COLYTE
Dosage Form : FOR SOLUTION;ORAL
Dosage Strength : 360GM/PACKET;4.47GM/PACKET;10.08GM/PACKET;8.76GM/PACKET;34.08GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 1984-10-26
Application Number : 18983
Regulatory Info : DISCN
Registration Country : USA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : DISCN
Registration Country : USA
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS
Brand Name : COLYTE
Dosage Form : FOR SOLUTION;ORAL
Dosage Strength : 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 1987-06-12
Application Number : 18983
Regulatory Info : DISCN
Registration Country : USA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : DISCN
Registration Country : USA
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS
Brand Name : COLYTE-FLAVORED
Dosage Form : FOR SOLUTION;ORAL
Dosage Strength : 227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 1991-11-14
Application Number : 18983
Regulatory Info : DISCN
Registration Country : USA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : DISCN
Registration Country : USA
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS
Brand Name : COLYTE-FLAVORED
Dosage Form : FOR SOLUTION;ORAL
Dosage Strength : 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 1991-11-14
Application Number : 18983
Regulatory Info : DISCN
Registration Country : USA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : DISCN
Registration Country : USA
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS
Brand Name : COLYTE
Dosage Form : FOR SOLUTION;ORAL
Dosage Strength : 227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 1989-01-31
Application Number : 18983
Regulatory Info : DISCN
Registration Country : USA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : DISCN
Registration Country : USA
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS
Brand Name : COLYTE WITH FLAVOR PACKS
Dosage Form : FOR SOLUTION;ORAL
Dosage Strength : 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT
Packaging :
Approval Date : 1998-10-08
Application Number : 18983
Regulatory Info : DISCN
Registration Country : USA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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