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Last Updated: December 14, 2025

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, Onesource Specialty, Regcon Holdings, Rising, Sagent Pharms Inc, Somerset Theraps Llc, Zydus Pharms, Alvogen, Am Regent, Conba Usa, Hospira, and Roxane, and is included in twenty-five NDAs. It is available from twelve 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. Fourteen suppliers are listed for this compound. Additional details are available on the acetylcysteine profile page.

Summary for 215620

Tradename:	ACETYLCYSTEINE
Applicant:	Regcon Holdings
Ingredient:	acetylcysteine
Patents:	0

Pharmacology for NDA: 215620

Mechanism of Action	Reduction Activity
Physiological Effect	Decreased Respiratory Secretion Viscosity Increased Glutathione Concentration

Medical Subject Heading (MeSH) Categories for 215620

Antiviral Agents
Expectorants
Free Radical Scavengers

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)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	6GM/30ML (200MG/ML)
Approval Date:	Feb 23, 2022	TE:	AP	RLD:	No

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