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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 215620


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NDA 215620 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 215620
Tradename:ACETYLCYSTEINE
Applicant:Indoco
Ingredient:acetylcysteine
Patents:0
Pharmacology for NDA: 215620
Medical Subject Heading (MeSH) Categories for 215620
Suppliers and Packaging for NDA: 215620
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACETYLCYSTEINE acetylcysteine INJECTABLE;INTRAVENOUS 215620 ANDA Indoco Remedies Limited 14445-412 14445-412-04 4 VIAL in 1 CARTON (14445-412-04) / 30 mL in 1 VIAL (14445-412-30)
ACETYLCYSTEINE acetylcysteine INJECTABLE;INTRAVENOUS 215620 ANDA Almaject, Inc. 72611-860 72611-860-04 4 VIAL, SINGLE-DOSE in 1 CARTON (72611-860-04) / 30 mL in 1 VIAL, SINGLE-DOSE (72611-860-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength6GM/30ML (200MG/ML)
Approval Date:Feb 23, 2022TE:APRLD:No

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