APPLICATION
ANDA209564
TYPE
ANDA
ORIGINAL APPROVAL
2021-02-09
LATEST ACTION
2024-07-03
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
LINACLOTIDEDiscontinued
LINACLOTIDE 145MCG · CAPSULE · ORAL
LINACLOTIDEDiscontinued
LINACLOTIDE 290MCG · CAPSULE · ORAL
Approval history
2024-07-03Labeling · Supplement 4 · standardAP
2022-05-18Labeling · Supplement 2 · standardAP
2022-05-18Labeling · Supplement 1 · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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