Orange Book product · Generic (ANDA)
PEG-LYTE
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS
At a glance
Aug 31, 1993
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 31, 1993
33 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS
Strength
236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT
Dosage form
FOR SUSPENSION
Route
ORAL
TE code
Not listed
Application
ANDA 073098
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS
- 1992GOLYTELYBrand (NDA)
NDA 019011 · AZURITY
- 1984COLYTEBrand (NDA)
NDA 018983 · STRIDES PHARMA INTL
- 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
- 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.
