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Details for New Drug Application (NDA): 072547

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NDA 072547 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: 072547

Tradename:
ACETYLCYSTEINE
Applicant:
Luitpold
Ingredient:
acetylcysteine
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 072547

Suppliers and Packaging for NDA: 072547

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACETYLCYSTEINE
acetylcysteine
SOLUTION;INHALATION, ORAL 072547 ANDA American Regent, Inc. 0517-7604 0517-7604-25 25 VIAL, GLASS in 1 TRAY (0517-7604-25) > 4 mL in 1 VIAL, GLASS
ACETYLCYSTEINE
acetylcysteine
SOLUTION;INHALATION, ORAL 072547 ANDA American Regent, Inc. 0517-7610 0517-7610-03 3 VIAL, GLASS in 1 BOX (0517-7610-03) > 10 mL in 1 VIAL, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATION, ORALStrength20%
Approval Date:Jul 28, 1995TE:ANRLD:Yes


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