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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 073664


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NDA 073664 describes ACETYLCYSTEINE, which is a drug marketed by Aspen, Eugia Pharma, Exela Pharma, Fresenius Kabi Usa, Indoco, Rising, Sagent Pharms Inc, Steriscience, Zydus Pharms, Alvogen, Am Regent, Hospira, and Roxane, and is included in twenty-two NDAs. It is available from thirteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the acetylcysteine profile page.
Summary for 073664
Tradename:ACETYLCYSTEINE
Applicant:Hospira
Ingredient:acetylcysteine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 073664
Medical Subject Heading (MeSH) Categories for 073664
Suppliers and Packaging for NDA: 073664
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACETYLCYSTEINE acetylcysteine SOLUTION;INHALATION, ORAL 073664 ANDA Hospira, Inc. 0409-3307 0409-3307-03 3 VIAL in 1 CARTON (0409-3307-03) / 30 mL in 1 VIAL (0409-3307-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATION, ORALStrength10%
Approval Date:Aug 30, 1994TE:ANRLD:No

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