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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. It is available from one supplier. 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. Ten 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. Ten 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 | 24338-700-10 | 10 BLISTER PACK in 1 CARTON (24338-700-10) > 2 TABLET, EFFERVESCENT in 1 BLISTER PACK (24338-700-02) |
| CETYLEV | acetylcysteine | TABLET, EFFERVESCENT;ORAL | 207916 | NDA | Arbor Pharmaceuticals | 24338-707 | 24338-707-04 | 2 BLISTER PACK in 1 CARTON (24338-707-04) > 2 TABLET, EFFERVESCENT in 1 BLISTER PACK (24338-707-02) |
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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