➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

AstraZeneca
Harvard Business School
McKesson
Express Scripts
McKinsey
Boehringer Ingelheim

Last Updated: December 1, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204674

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

NDA 204674 describes ACETYLCYSTEINE, which is a drug marketed by Akorn Inc, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Mylan Institutional, Sagent Pharms Inc, Zydus Pharms, Alvogen, Am Regent, Hospira, and Roxane, and is included in eighteen NDAs. It is available from nine 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 204674
Tradename:ACETYLCYSTEINE
Applicant:Alvogen
Ingredient:acetylcysteine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204674
Medical Subject Heading (MeSH) Categories for 204674
Suppliers and Packaging for NDA: 204674
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACETYLCYSTEINE acetylcysteine SOLUTION;INHALATION, ORAL 204674 ANDA Fresenius Kabi USA, LLC 63323-691 63323-691-30 3 VIAL in 1 CARTON (63323-691-30) > 30 mL in 1 VIAL
ACETYLCYSTEINE acetylcysteine SOLUTION;INHALATION, ORAL 204674 ANDA Fresenius Kabi USA, LLC 63323-693 63323-693-10 3 VIAL in 1 CARTON (63323-693-10) > 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATION, ORALStrength10%
Approval Date:Feb 11, 2014TE:ANRLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Medtronic
McKesson
Dow
Express Scripts
Harvard Business School
Merck

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.