← FDA Drug Approvals (Drugs@FDA)
DIFICID
NDA · New Drug Application · Sponsor: CUBIST PHARMS LLC · Approved 2011-05-27
Drug application
- FDA Application #
NDA201699- Application type
- New Drug Application
- Brand name
- DIFICID
- Generic name
- FIDAXOMICIN
- Active ingredients
- FIDAXOMICIN
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- CUBIST PHARMS LLC
- Manufacturer
- Merck Sharp & Dohme LLC
- First approval
- 2011-05-27
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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