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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 202788


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NDA 202788 describes SUBSYS, which is a drug marketed by Btcp Pharma and is included in one NDA. There are ten patents protecting this drug and two Paragraph IV challenges. Additional details are available on the SUBSYS profile page.

The generic ingredient in SUBSYS is fentanyl. There are thirty-one drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the fentanyl profile page.
Summary for 202788
Tradename:SUBSYS
Applicant:Btcp Pharma
Ingredient:fentanyl
Patents:10
Medical Subject Heading (MeSH) Categories for 202788

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SPRAY;SUBLINGUALStrength0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jan 4, 2012TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Jan 25, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Jan 25, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Apr 27, 2030Product Flag?YSubstance 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 verification 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.