Details for New Drug Application (NDA): 207916
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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: | DISCN | Dosage: | TABLET, EFFERVESCENT;ORAL | Strength | 500MG | ||||
Approval Date: | Jan 29, 2016 | TE: | RLD: | Yes | |||||
Patent: | 8,747,894 | Patent Expiration: | May 8, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS | ||||||||
Patent: | 9,427,421 | Patent Expiration: | May 8, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | 9,561,204 | Patent Expiration: | May 8, 2032 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS |
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