Details for New Drug Application (NDA): 021539

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NDA 021539 describes ACETADOTE, which is a drug marketed by Cumberland Pharms and is included in one NDA. It is available from two suppliers. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ACETADOTE profile page.

The generic ingredient in ACETADOTE 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 021539

Tradename:	ACETADOTE
Applicant:	Cumberland Pharms
Ingredient:	acetylcysteine
Patents:	5

Pharmacology for NDA: 021539

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

Medical Subject Heading (MeSH) Categories for 021539

Antiviral Agents
Expectorants
Free Radical Scavengers

Suppliers and Packaging for NDA: 021539

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACETADOTE	acetylcysteine	INJECTABLE;INTRAVENOUS	021539	NDA AUTHORIZED GENERIC	Padagis US LLC	0574-0805	0574-0805-30	4 VIAL in 1 CARTON (0574-0805-30) / 30 mL in 1 VIAL
ACETADOTE	acetylcysteine	INJECTABLE;INTRAVENOUS	021539	NDA	Cumberland Pharmaceuticals Inc.	66220-207	66220-207-30	4 VIAL in 1 CARTON (66220-207-30) / 30 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	6GM/30ML (200MG/ML)
Approval Date:	Jan 23, 2004	TE:	AP	RLD:	Yes
Regulatory Exclusivity Expiration:	Nov 26, 2027
Regulatory Exclusivity Use:	ADDITION OF A TWO-BAG DOSING REGIMEN
Patent:	⤷ Get Started Free	Patent Expiration:	May 21, 2026	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Get Started Free	Patent Expiration:	Aug 24, 2025	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS

Expired US Patents for NDA 021539

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cumberland Pharms	ACETADOTE	acetylcysteine	INJECTABLE;INTRAVENOUS	021539-001	Jan 23, 2004	⤷ Get Started Free	⤷ Get Started Free
Cumberland Pharms	ACETADOTE	acetylcysteine	INJECTABLE;INTRAVENOUS	021539-001	Jan 23, 2004	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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