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Last Updated: June 14, 2024

Details for New Drug Application (NDA): 201699


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NDA 201699 describes DIFICID, which is a drug marketed by Cubist Pharms Llc and is included in two NDAs. It is available from one supplier. There are six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the DIFICID profile page.

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.
Summary for 201699
Tradename:DIFICID
Applicant:Cubist Pharms Llc
Ingredient:fidaxomicin
Patents:5
Pharmacology for NDA: 201699
Suppliers and Packaging for NDA: 201699
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIFICID fidaxomicin TABLET;ORAL 201699 NDA Merck Sharp & Dohme LLC 52015-080 52015-080-01 1 BOTTLE in 1 CARTON (52015-080-01) / 20 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:May 27, 2011TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Jan 24, 2027
Regulatory Exclusivity Use:PEDIATRIC PATIENTS AGED 6 MONTHS AND OLDER FOR THE TREATMENT OF C. DIFFICILE-ASSOCIATED DIARRHEA (CDAD)
Patent:⤷  Sign UpPatent Expiration:Jan 31, 2028Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Sign UpPatent Expiration:Jan 31, 2028Product Flag?Substance Flag?Delist Request?Y

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