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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 207916


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NDA 207916 describes CETYLEV, which is a drug marketed by Arbor Pharms Llc and is included in one NDA. There are three patents protecting this drug. Additional details are available on the CETYLEV profile page.

The generic ingredient in CETYLEV is acetylcysteine. There are three drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the acetylcysteine profile page.
Summary for 207916
Tradename:CETYLEV
Applicant:Arbor Pharms Llc
Ingredient:acetylcysteine
Patents:3
Medical Subject Heading (MeSH) Categories for 207916

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EFFERVESCENT;ORALStrength500MG
Approval Date:Jan 29, 2016TE:RLD:Yes
Patent:8,747,894Patent Expiration:May 8, 2032Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS
Patent:9,427,421Patent Expiration:May 8, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:9,561,204Patent Expiration:May 8, 2032Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS

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