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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 204553

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NDA 204553 describes COLPREP KIT, which is a drug marketed by Gator Pharms and is included in one NDA. Additional details are available on the COLPREP KIT profile page.

The generic ingredient in COLPREP KIT is magnesium sulfate; potassium sulfate; sodium sulfate. There are one hundred and forty-six drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the magnesium sulfate; potassium sulfate; sodium sulfate profile page.

Summary for 204553

Tradename:	COLPREP KIT
Applicant:	Gator Pharms
Ingredient:	magnesium sulfate; potassium sulfate; sodium sulfate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	POWDER;ORAL			Strength	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT
Approval Date:	Dec 27, 2016	TE:		RLD:	Yes

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