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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204559
Company: STRIDES PHARMA

Products on ANDA 204559

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 204559

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/13/2015	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
06/06/2024	SUPPL-19	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/06/2024	SUPPL-16	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 204559

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

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