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Details for New Drug Application (NDA): 021492

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NDA 021492 describes ELOXATIN, which is a drug marketed by Sanofi Aventis Us and is included in two NDAs. It is available from three suppliers. There are two patents protecting this drug and four Paragraph IV challenges. Additional details are available on the ELOXATIN profile page.

The generic ingredient in ELOXATIN is oxaliplatin. There are twenty-six drug master file entries for this compound. Fifteen suppliers are listed for this compound. There are eight tentative approvals for this compound. Additional details are available on the oxaliplatin profile page.

Summary for NDA: 021492

Tradename:
ELOXATIN
Applicant:
Sanofi Aventis Us
Ingredient:
oxaliplatin
Patents:1
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;IV (INFUSION)Strength50MG/VIAL
Approval Date:Aug 9, 2002TE:RLD:No
Patent:5,420,319*PEDPatent Expiration:Feb 9, 2017Product Flag?Substance Flag?Delist Request?Y

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;IV (INFUSION)Strength100MG/VIAL
Approval Date:Aug 9, 2002TE:RLD:No
Patent:5,420,319*PEDPatent Expiration:Feb 9, 2017Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021492

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
ELOXATIN
oxaliplatin
INJECTABLE;IV (INFUSION)021492-001Aug 9, 20025,290,961*PED► subscribe
Sanofi Aventis Us
ELOXATIN
oxaliplatin
INJECTABLE;IV (INFUSION)021492-002Aug 9, 20025,338,874*PED► subscribe
Sanofi Aventis Us
ELOXATIN
oxaliplatin
INJECTABLE;IV (INFUSION)021492-002Aug 9, 20025,290,961*PED► subscribe
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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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