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Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021539

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NDA 021539 describes ACETADOTE, which is a drug marketed by Cumberland Pharms and is included in one NDA. It is available from two suppliers. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ACETADOTE profile page.

The generic ingredient in ACETADOTE 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 021539
Tradename:ACETADOTE
Applicant:Cumberland Pharms
Ingredient:acetylcysteine
Patents:5
Formulation / Manufacturing:see details
Pharmacology for NDA: 021539
Medical Subject Heading (MeSH) Categories for 021539
Suppliers and Packaging for NDA: 021539
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACETADOTE acetylcysteine INJECTABLE;INTRAVENOUS 021539 NDA Paddock Laboratories, LLC 0574-0805 N 0574-0805-30
ACETADOTE acetylcysteine INJECTABLE;INTRAVENOUS 021539 NDA Paddock Laboratories, LLC 0574-0815 N 0574-0815-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength6GM/30ML (200MG/ML)
Approval Date:Jan 23, 2004TE:APRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:May 21, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Aug 24, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS
Patent:➤ Try a Free TrialPatent Expiration:Aug 24, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS

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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
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