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ACTIVE SUBSTANCE / INN

LINACLOTIDE

Brand name(s): Constella, LINZESS, LINACLOTIDE
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
ANDA211255
ANDA209611
ACTIVE SUBSTANCE
Linaclotide
REGULATORS
FDA · EMA
SPONSORS / MAH
AbbVie Deutschland GmbH & Co. KG, ACTAVIS LABS FL INC, AUROBINDO PHARMA
TOTAL APPLICATIONS
4
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
LINZESSNDA202811ABBVIEPrescription
LINACLOTIDEANDA209611AUROBINDO PHARMADiscontinued
LINACLOTIDEANDA211255ACTAVIS LABS FL INCNone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
ConstellaAbbVie Deutschland GmbH & Co. KGAuthorised26/11/2012Irritable Bowel Syndrome

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