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The generic ingredient in DIFICID is fidaxomicin. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fidaxomicin profile page.
Generic Entry Opportunity Date for 201699
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 201699
Suppliers and Packaging for NDA: 201699
Profile for product number 001
|Approval Date:||May 27, 2011||TE:||RLD:||Yes|
|Regulatory Exclusivity Expiration:||Jan 24, 2023|
|Regulatory Exclusivity Use:||NEW PATIENT POPULATION|
|Regulatory Exclusivity Expiration:||Jul 24, 2023|
|Regulatory Exclusivity Use:||PEDIATRIC EXCLUSIVITY|
|Patent:||Start Trial||Patent Expiration:||Jan 31, 2028||Product Flag?||Substance Flag?||Delist Request?||Y|
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