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Last Updated: December 1, 2020

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Details for New Drug Application (NDA): 208166

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NDA 208166 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 208166
Tradename:ACETYLCYSTEINE
Applicant:Zydus Pharms
Ingredient:acetylcysteine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 208166
Medical Subject Heading (MeSH) Categories for 208166
Suppliers and Packaging for NDA: 208166
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACETYLCYSTEINE acetylcysteine INJECTABLE;INTRAVENOUS 208166 ANDA Zydus Pharmaceuticals (USA) Inc. 70710-1015 70710-1015-8 4 VIAL in 1 CARTON (70710-1015-8) > 30 mL in 1 VIAL (70710-1015-1)
ACETYLCYSTEINE acetylcysteine INJECTABLE;INTRAVENOUS 208166 ANDA Cadila Healthcare Limited 70771-1412 70771-1412-8 4 VIAL in 1 CARTON (70771-1412-8) > 30 mL in 1 VIAL (70771-1412-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength6GM/30ML (200MG/ML)
Approval Date:Jul 20, 2018TE:APRLD:No

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