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Last Updated: November 12, 2024

Details for New Drug Application (NDA): 213138


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NDA 213138 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 213138
Tradename:DIFICID
Applicant:Cubist Pharms Llc
Ingredient:fidaxomicin
Patents:6
Pharmacology for NDA: 213138
Suppliers and Packaging for NDA: 213138
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIFICID fidaxomicin FOR SUSPENSION;ORAL 213138 NDA Merck Sharp & Dohme LLC 52015-700 52015-700-22 1 POUCH in 1 CARTON (52015-700-22) / 1 BOTTLE, GLASS in 1 POUCH (52015-700-23) / 150 mL in 1 BOTTLE, GLASS (52015-700-21)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength40MG/ML
Approval Date:Jan 24, 2020TE:RLD: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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