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FDA Orange Book · active-ingredient family

Polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous

Polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous is approved as 2 brand and 11 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:GOLYTELY · NDA 019011

2

Brand (NDA)

11

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · for solution, for suspension

ProductApplicantApplicationTEApproved
GOLYTELYRLD×2AZURITYNDA 019011—Jun 02, 1992
COLYTERLD×8STRIDES PHARMA INTLNDA 018983—Oct 26, 1984

Generic (ANDA) products (11)

ProductApplicantApplicationTEApproved
POLYETHYLENE GLYCOL 3350 AND ELECTROLYTESSTRIDES PHARMAANDA 204558AADec 21, 2018
POLYETHYLENE GLYCOL 3350 AND ELECTROLYTESPADDOCK LLCANDA 090712—Feb 25, 2010
PEG 3350 AND ELECTROLYTESEXTROVISANDA 090928—Jan 28, 2010
PEG 3350 AND ELECTROLYTESNOVEL LABS INCANDA 090231AAJun 01, 2009
PEG 3350 AND ELECTROLYTESNOVEL LABS INCANDA 090186—Jun 01, 2009
PEG-LYTESANDOZANDA 073098—Aug 31, 1993
GO-EVACVINTAGE PHARMSANDA 073433—Apr 28, 1992
CO-LAVVINTAGE PHARMSANDA 073428—Jan 28, 1992
GLYCOPREPGOLDLINEANDA 072319—Dec 23, 1988
E-Z-EM PREP LYTEE Z EMANDA 071278—Nov 21, 1988
COLOVAGEDYNAPHARMANDA 071320—Apr 20, 1988

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.

Polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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