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Generated: November 21, 2018

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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. 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.
Summary for 207916
Tradename:CETYLEV
Applicant:Arbor Pharms Llc
Ingredient:acetylcysteine
Patents:3
Formulation / Manufacturing:see details
Pharmacology for NDA: 207916
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:RXDosage:TABLET, EFFERVESCENT;ORALStrength500MG
Approval Date:Jan 29, 2016TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:May 8, 2032Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS
Patent:➤ Try a Free TrialPatent Expiration:May 8, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:May 8, 2032Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS

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