FDA.reportPublic FDA data

Application 212555

Type
ANDA
Sponsor
GLENMARK PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002NINTEDANIBNINTEDANIB ESYLATECAPSULE;ORALEQ 150MG BASENoNo

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 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
nintedanibNINTEDANIBAvKARE572722d7-338a-e4d2-e063-6394a90a257c2026-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212555
application number: ANDA212555
nintedanibNINTEDANIBGlenmark Pharmaceuticals Inc., USAb14164fb-0276-4ad1-a5ff-400ab9e292da2026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212555
application number: ANDA212555

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68025ORIG2021-07-07