Details for New Drug Application (NDA): 021551

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NDA 021551 describes HALFLYTELY, which is a drug marketed by Braintree and is included in one NDA. Additional details are available on the HALFLYTELY profile page.

The generic ingredient in HALFLYTELY is bisacodyl; polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the bisacodyl; polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride profile page.

Summary for 021551

Tradename:	HALFLYTELY
Applicant:	Braintree
Ingredient:	bisacodyl; polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride
Patents:	0

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL			Strength	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jul 16, 2010	TE:		RLD:	Yes

Expired US Patents for NDA 021551

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Braintree	HALFLYTELY	bisacodyl; polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride	FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL	021551-003	Jul 16, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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