AMITIZA
These highlights do not include all the information needed to use AMITIZA safely and effectively. See full prescribing information for AMITIZA. AMITIZA (lubiprostone) capsule, gelatin coated for oral use Initial U.S. Approval: 2006
Approved
Approval ID
ca79dddc-3911-472b-bda7-a23351be09af
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 21, 2010
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
LUBIPROSTONE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-622
Application NumberNDA021908
Product Classification
M
Marketing Category
C73594
G
Generic Name
LUBIPROSTONE
Product Specifications
Route of AdministrationORAL
Effective DateJuly 21, 2010
FDA Product Classification
INGREDIENTS (7)
LUBIPROSTONEActive
Quantity: 8 ug in 1 1
Code: 7662KG2R6K
Classification: ACTIB
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT