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Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074037

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NDA 074037 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 074037

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

Pharmacology for NDA: 074037

Medical Subject Heading (MeSH) Categories for 074037

Suppliers and Packaging for NDA: 074037

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACETYLCYSTEINE acetylcysteine SOLUTION;INHALATION, ORAL 074037 ANDA Hospira, Inc. 0409-3308 0409-3308-03 3 VIAL in 1 CARTON (0409-3308-03) > 30 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATION, ORALStrength20%
Approval Date:Aug 30, 1994TE:ANRLD:No


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US Department of Justice
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Harvard Business School
Johnson and Johnson

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