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Serving leading biopharmaceutical companies globally:

McKesson
Citi
Medtronic
Covington
Cerilliant
Dow
US Army
Express Scripts
Harvard Business School
Federal Trade Commission

Generated: January 20, 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 seven 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. Ten 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 54868-5670-0 1 VIAL in 1 BOTTLE, DISPENSING (54868-5670-0) > 30 mL in 1 VIAL

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 leading biopharmaceutical companies globally:

Deloitte
Dow
Cipla
Medtronic
Covington
Queensland Health
Argus Health
Fish and Richardson
Mallinckrodt

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