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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. There is one patent protecting this drug and two Paragraph IV challenges. 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 NDA: 021551

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:FOR SOLUTION, TABLET, DELAYED RELEASE;ORALStrength5MG,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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jul 16, 2010TE:RLD:Yes
Patent:7,291,324Patent Expiration:Oct 22, 2022Product Flag?Substance Flag?Delist Request?

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.