Details for New Drug Application (NDA): 022372

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NDA 022372 describes SUPREP BOWEL PREP KIT, which is a drug marketed by Braintree Labs and is included in one NDA. It is available from two suppliers. Additional details are available on the SUPREP BOWEL PREP KIT profile page.

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

Summary for 022372

Tradename:	SUPREP BOWEL PREP KIT
Applicant:	Braintree Labs
Ingredient:	magnesium sulfate; potassium sulfate; sodium sulfate
Patents:	0

Pharmacology for NDA: 022372

Mechanism of Action	Magnesium Ion Exchange Activity Osmotic Activity
Physiological Effect	Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption Inhibition Small Intestine Fluid/Electrolyte Absorption Stimulation Large Intestine Fluid/Electrolyte Secretion

Suppliers and Packaging for NDA: 022372

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SUPREP BOWEL PREP KIT	magnesium sulfate; potassium sulfate; sodium sulfate	SOLUTION;ORAL	022372	NDA	Affordable Pharmaceuticals, LLC	10572-012	10572-012-01	2 BOTTLE, PLASTIC in 1 CARTON (10572-012-01) / 177.4 mL in 1 BOTTLE, PLASTIC
SUPREP BOWEL PREP KIT	magnesium sulfate; potassium sulfate; sodium sulfate	SOLUTION;ORAL	022372	NDA	Affordable Pharmaceuticals, LLC	10572-112	10572-112-01	2 BOTTLE, PLASTIC in 1 CARTON (10572-112-01) / 133.1 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT
Approval Date:	Aug 5, 2010	TE:	AA	RLD:	Yes
Regulatory Exclusivity Expiration:	Aug 5, 2027
Regulatory Exclusivity Use:	FOR CLEANSING OF THE COLON AS A PREPARATION FOR COLONOSCOPY IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

Expired US Patents for NDA 022372

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Braintree Labs	SUPREP BOWEL PREP KIT	magnesium sulfate; potassium sulfate; sodium sulfate	SOLUTION;ORAL	022372-001	Aug 5, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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