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Details for New Drug Application (NDA): 201699
The generic ingredient in DIFICID is fidaxomicin. There are two drug master file entries for this compound. Two suppliers are 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
Ingredient-type | Macrolides |
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 Corp. | 52015-080 | N | 52015-080-01 |
DIFICID | fidaxomicin | TABLET;ORAL | 201699 | NDA | Avera McKennan Hospital | 69189-0083 | N | 69189-0083-1 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | May 27, 2011 | TE: | RLD: | Yes | |||||
Patent: | ➤ Try a Free Trial | Patent Expiration: | Jul 31, 2027 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patent: | ➤ Try a Free Trial | Patent Expiration: | Jul 31, 2027 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patent: | ➤ Try a Free Trial | Patent Expiration: | Mar 4, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF MICROBIAL INFECTIONS |
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