← FDA Drug Approvals (Drugs@FDA)
AMITIZA
NDA · New Drug Application · Sponsor: SUCAMPO PHARMA LLC · Approved 2006-01-31
Drug application
- FDA Application #
NDA021908- Application type
- New Drug Application
- Brand name
- AMITIZA
- Generic name
- LUBIPROSTONE
- Active ingredients
- LUBIPROSTONE
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- SUCAMPO PHARMA LLC
- Manufacturer
- Dr. Reddy's Laboratories Inc.
- First approval
- 2006-01-31
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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