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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 072547

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NDA 072547 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 072547

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 072547

Medical Subject Heading (MeSH) Categories for 072547

Suppliers and Packaging for NDA: 072547

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACETYLCYSTEINE acetylcysteine SOLUTION;INHALATION, ORAL 072547 ANDA American Regent, Inc. 0517-7604 0517-7604-25 25 VIAL, GLASS in 1 TRAY (0517-7604-25) > 4 mL in 1 VIAL, GLASS
ACETYLCYSTEINE acetylcysteine SOLUTION;INHALATION, ORAL 072547 ANDA American Regent, Inc. 0517-7610 0517-7610-03 3 VIAL, GLASS in 1 BOX (0517-7610-03) > 10 mL in 1 VIAL, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATION, ORALStrength20%
Approval Date:Jul 28, 1995TE:ANRLD:No


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