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Generated: September 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203853

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NDA 203853 describes ACETYLCYSTEINE, which is a drug marketed by Roxane, Mylan Institutional, Hospira, Fresenius Kabi Usa, Luitpold, Alvogen Inc, Aurobindo Pharma Ltd, and Akorn Inc, and is included in sixteen 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 NDA: 203853

Formulation / Manufacturing:see details

Pharmacology for NDA: 203853

Suppliers and Packaging for NDA: 203853

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOLUTION;INHALATION, ORAL 203853 ANDA Fresenius Kabi USA, LLC 63323-690 63323-690-30 3 VIAL in 1 CARTON (63323-690-30) > 30 mL in 1 VIAL
SOLUTION;INHALATION, ORAL 203853 ANDA Fresenius Kabi USA, LLC 63323-692 63323-692-10 3 VIAL in 1 CARTON (63323-692-10) > 10 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATION, ORALStrength20%
Approval Date:Jun 21, 2012TE:ANRLD:No

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Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
Johnson and Johnson
US Army
Federal Trade Commission

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