Details for New Drug Application (NDA): 213138
✉ Email this page to a colleague
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 |
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: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 40MG/ML | ||||
Approval Date: | Jan 24, 2020 | TE: | 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 Up | Patent Expiration: | Jan 31, 2028 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 31, 2028 | Product Flag? | Substance Flag? | Delist Request? | Y |
Complete Access Available with Subscription