Details for New Drug Application (NDA): 215344

NDA 215344 describes SUFLAVE, which is a drug marketed by Braintree Labs and is included in one NDA. It is available from one supplier. Additional details are available on the SUFLAVE profile page.

The generic ingredient in SUFLAVE is magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium 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; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate profile page.

Summary for 215344

Tradename:	SUFLAVE
Applicant:	Braintree Labs
Ingredient:	magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate
Patents:	0

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 215344

Constraining patent/regulatory exclusivity:

NEW PRODUCT

Dosage:

FOR SOLUTION;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.

Suppliers and Packaging for NDA: 215344

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SUFLAVE	magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate	FOR SOLUTION;ORAL	215344	NDA	Braintree Laboratories, Inc.	52268-550	52268-550-01	1 KIT in 1 KIT (52268-550-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SOLUTION;ORAL			Strength	0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT
Approval Date:	Jun 15, 2023	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Jun 15, 2026
Regulatory Exclusivity Use:	NEW PRODUCT

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