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Details for New Drug Application (NDA): 207916
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 |
Pharmacology for NDA: 207916
Mechanism of Action | Reduction Activity |
Physiological Effect | Decreased Respiratory Secretion Viscosity Increased Glutathione Concentration |
Medical Subject Heading (MeSH) Categories for 207916
Suppliers and Packaging for NDA: 207916
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CETYLEV | acetylcysteine | TABLET, EFFERVESCENT;ORAL | 207916 | NDA | Arbor Pharmaceuticals | 24338-700 | N | 24338-700-10 |
CETYLEV | acetylcysteine | TABLET, EFFERVESCENT;ORAL | 207916 | NDA | Arbor Pharmaceuticals | 24338-707 | N | 24338-707-04 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EFFERVESCENT;ORAL | Strength | 500MG | ||||
Approval Date: | Jan 29, 2016 | TE: | RLD: | Yes | |||||
Patent: | ➤ Try a Free Trial | Patent Expiration: | May 8, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS | ||||||||
Patent: | ➤ Try a Free Trial | Patent Expiration: | May 8, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ➤ Try a Free 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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