An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 090019
Company: NOVEL LABS INC

Products on ANDA 090019

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090019

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/27/2009	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/23/2023	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
12/21/2020	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
10/05/2009	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 090019

PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE

FOR SOLUTION;ORAL; 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NULYTELY	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION;ORAL	Prescription	Yes	AA	019797	AZURITY
NULYTELY-FLAVORED	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION;ORAL	Prescription	Yes	AA	019797	AZURITY
PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION;ORAL	Prescription	No	AA	090019	NOVEL LABS INC
PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION;ORAL	Prescription	No	AA	204559	STRIDES PHARMA
TRILYTE	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION;ORAL	Prescription	No	AA	076491	AUROBINDO PHARMA USA

Top