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Last Updated: November 25, 2024

Details for New Drug Application (NDA): 204674


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NDA 204674 describes ACETYLCYSTEINE, which is a drug marketed by Eugia Pharma, Exela Pharma, Fresenius Kabi Usa, Glenmark Pharms Inc, Indoco, Rising, Sagent Pharms Inc, Somerset Theraps Llc, Steriscience Speclts, Zydus Pharms, Alvogen, Am Regent, Hospira, and Roxane, and is included in twenty-three NDAs. It is available from fourteen 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. Sixteen 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
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 (63323-691-22)
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 (63323-693-22)

Profile for product number 001

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

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