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Details for New Drug Application (NDA): 022273

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NDA 022273 describes OFORTA, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. There are two patents protecting this drug. Additional details are available on the OFORTA profile page.

The generic ingredient in OFORTA is fludarabine phosphate. There are ten drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the fludarabine phosphate profile page.

Summary for NDA: 022273

Sanofi Aventis Us
fludarabine phosphate

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG
Approval Date:Dec 18, 2008TE:RLD:No
Patent:7,547,776Patent Expiration:Dec 10, 2018Product Flag?Substance Flag?YDelist Request?
Regulatory Exclusivity Expiration:Dec 18, 2015
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Patent:7,148,207Patent Expiration:Dec 20, 2022Product Flag?YSubstance Flag?Delist Request?

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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.