FDA.reportPublic FDA data

Application 211255

Type
ANDA
Sponsor
ACTAVIS LABS FL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LINACLOTIDELINACLOTIDECAPSULE;ORAL72MCGNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LinzessLINACLOTIDEAllergan, Inc.09beda19-56d6-4a56-afdc-9a77b70b2ef32026-05-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LINACLOTIDE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71679ORIG2022-08-01