Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021908

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AMITIZA (LUBIPROSTONE)
8MCG Marketing Status: Prescription

Active Ingredient: LUBIPROSTONE
Proprietary Name: AMITIZA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 8MCG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021908
Product Number: 002
Approval Date: Apr 29, 2008
Applicant Holder Full Name: SUCAMPO PHARMA AMERICAS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

AMITIZA (LUBIPROSTONE)
24MCG Marketing Status: Prescription

Active Ingredient: LUBIPROSTONE
Proprietary Name: AMITIZA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 24MCG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021908
Product Number: 001
Approval Date: Jan 31, 2006
Applicant Holder Full Name: SUCAMPO PHARMA AMERICAS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

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