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Details for New Drug Application (NDA): 207916
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. Eleven suppliers are listed for this compound. Additional details are available on the acetylcysteine profile page.
The generic ingredient in CETYLEV is acetylcysteine. There are three drug master file entries for this compound. Eleven 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 |
| Formulation / Manufacturing: | see details |
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: | Start Trial | Patent Expiration: | May 8, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS | ||||||||
| Patent: | Start Trial | Patent Expiration: | May 8, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | Start Trial | 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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