Details for New Drug Application (NDA): 213135

NDA 213135 describes SUTAB, which is a drug marketed by Braintree Labs and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the SUTAB profile page.

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

Summary for 213135

Tradename:	SUTAB
Applicant:	Braintree Labs
Ingredient:	magnesium sulfate; potassium chloride; sodium sulfate
Patents:	4

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 213135

Constraining patent/regulatory exclusivity:

11,382,864

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 213135

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: 213135

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SUTAB	magnesium sulfate; potassium chloride; sodium sulfate	TABLET;ORAL	213135	NDA	Braintree Laboratories, Inc.	52268-201	52268-201-01	2 BOTTLE, PLASTIC in 1 KIT (52268-201-01) / 12 TABLET in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.225GM;0.188GM;1.479GM
Approval Date:	Nov 10, 2020	TE:		RLD:	Yes
Patent:	10,143,656	Patent Expiration:	Aug 4, 2037	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	11,033,498	Patent Expiration:	Aug 4, 2037	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	GASTROINTESTINAL TABLETS INDICATED FOR CLEANSING THE COLON IN PREPARATION FOR COLONOSCOPY
Patent:	11,382,864	Patent Expiration:	Aug 4, 2037	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	GASTROINTESTINAL TABLETS INDICATED FOR CLEANSING THE COLON IN PREPARATION FOR COLONOSCOPY

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