Orange Book product · Brand (NDA)
COLYTE-FLAVORED
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS
At a glance
Nov 14, 1991
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 14, 1991
35 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS
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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
FOR SOLUTION
Route
ORAL
TE code
Not listed
Application
NDA 018983
Product number
009
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1992GOLYTELYBrand (NDA)
NDA 019011 · AZURITY
- 2018POLYETHYLENE GLYCOL 3350 AND ELECTROLYTESGeneric (ANDA)
ANDA 204558 · STRIDES PHARMA
- 2010POLYETHYLENE GLYCOL 3350 AND ELECTROLYTESGeneric (ANDA)
ANDA 090712 · PADDOCK LLC
- 2010PEG 3350 AND ELECTROLYTESGeneric (ANDA)
ANDA 090928 · EXTROVIS
- 2009PEG 3350 AND ELECTROLYTESGeneric (ANDA)
ANDA 090231 · NOVEL LABS INC
- 2009PEG 3350 AND ELECTROLYTESGeneric (ANDA)
ANDA 090186 · NOVEL LABS INC
- 1993PEG-LYTEGeneric (ANDA)
ANDA 073098 · SANDOZ
- 1992GO-EVACGeneric (ANDA)
ANDA 073433 · VINTAGE PHARMS
- 1992CO-LAVGeneric (ANDA)
ANDA 073428 · VINTAGE PHARMS
- 1988GLYCOPREPGeneric (ANDA)
ANDA 072319 · GOLDLINE
- 1988E-Z-EM PREP LYTEGeneric (ANDA)
ANDA 071278 · E Z EM
- 1988COLOVAGEGeneric (ANDA)
ANDA 071320 · DYNAPHARM
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
