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Last Updated: September 23, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203853


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NDA 203853 describes ACETYLCYSTEINE, which is a drug marketed by Akorn, Aurobindo Pharma Ltd, Exela Pharma, Fresenius Kabi Usa, Mylan Institutional, Sagent Pharms Inc, Zydus Pharms, Alvogen, Am Regent, Hospira, and Roxane, and is included in nineteen NDAs. It is available from ten 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. Twelve suppliers are listed for this compound. Additional details are available on the acetylcysteine profile page.
Summary for 203853
Tradename:ACETYLCYSTEINE
Applicant:Alvogen
Ingredient:acetylcysteine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203853
Medical Subject Heading (MeSH) Categories for 203853
Suppliers and Packaging for NDA: 203853
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACETYLCYSTEINE acetylcysteine 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
ACETYLCYSTEINE acetylcysteine SOLUTION;INHALATION, ORAL 203853 ANDA Fresenius Kabi USA, LLC 63323-690 63323-690-44 3 VIAL in 1 CARTON (63323-690-44) > 30 mL in 1 VIAL (63323-690-41)

Profile for product number 001

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

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