Orange Book product · Brand (NDA)
COLYTE
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS
At a glance
Jan 31, 1989
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 31, 1989
37 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS
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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
FOR SOLUTION
Route
ORAL
TE code
Not listed
Application
NDA 018983
Product number
010
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.
