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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. Ten suppliers are listed for this compound. Additional details are available on the acetylcysteine profile page.

Summary for NDA: 021539

Tradename:
ACETADOTE
Applicant:
Cumberland Pharms
Ingredient:
acetylcysteine
Patents:5
Formulation / Manufacturing:see details

Pharmacology for NDA: 021539

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 Paddock Laboratories, 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 Paddock Laboratories, LLC 0574-0815 0574-0815-30 4 VIAL in 1 CARTON (0574-0815-30) > 30 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength6GM/30ML (200MG/ML)
Approval Date:Jan 23, 2004TE:APRLD:Yes
Patent:8,148,356Patent Expiration:May 21, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:9,327,028Patent Expiration:Jul 21, 2031Product Flag?Substance Flag?Delist Request?
Patented Use:COMPOSITION AND METHOD FOR PROVIDING A REDUCTION IN SIDE EFFECTS FOR HUMAN PATIENTS IN NEED OF ACETYLCYSTEINE THERAPY
Patent:8,399,445Patent Expiration:Aug 24, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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