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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
McKinsey
McKesson
Fuji
Argus Health
Cantor Fitzgerald
UBS
AstraZeneca
Johnson and Johnson

Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 072324

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NDA 072324 describes ACETYLCYSTEINE, which is a drug marketed by Akorn Inc, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Mylan Institutional, Sagent Pharms, Alvogen Inc, Hospira, Luitpold, and Roxane, and is included in seventeen NDAs. It is available from eight suppliers. Additional details are available on the ACETYLCYSTEINE profile page.

The generic ingredient in ACETYLCYSTEINE 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 072324
Tradename:ACETYLCYSTEINE
Applicant:Roxane
Ingredient:acetylcysteine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 072324
Medical Subject Heading (MeSH) Categories for 072324
Suppliers and Packaging for NDA: 072324
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACETYLCYSTEINE acetylcysteine SOLUTION;INHALATION, ORAL 072324 ANDA Physicians Total Care, Inc. 54868-5670 E 54868-5670-0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INHALATION, ORALStrength20%
Approval Date:Apr 30, 1992TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Federal Trade Commission
Merck
Healthtrust
Fish and Richardson
Daiichi Sankyo
Accenture
AstraZeneca
Deloitte

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