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OCALIVA (nda207999)- (5MG,10MG)

OBETICHOLIC ACID INTERCEPT PHARMS INC
5MG,10MG
Yes No
2036-Apr-26 2021-May-27
2023-May-27 None
None No
OCALIVA, a farnesoid X receptor (FXR) agonist, is indicated for the treatment of adult patients with primary biliary cholangitis (PBC) • without cirrhosis or • with compensated cirrhosis who do not have evidence of portal hypertension, either in combination with ursodeoxycholic acid (UDCA) with an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA.
3 3 0
Total Other Developers 13
Drugs with Suitability No
5MG ** ** - - -
10MG ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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Brand Name Generic Name Strength Dosage Route of Administration Innovator ParaIV

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