FDA.reportPublic FDA data

Application 210212

Type
ANDA
Sponsor
MSN LABORATORIES PRIVATE LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALOGLIPTIN AND METFORMIN HYDROCHLORIDEALOGLIPTIN AND METFORMIN HYDROCHLORIDETABLET; ORAL12.5MG/500MGNoNo
002ALOGLIPTIN AND METFORMIN HYDROCHLORIDEALOGLIPTIN AND METFORMIN HYDROCHLORIDETABLET; ORAL12.5MG/1000MGNoNo

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 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
alogliptin and metformin hydrochlorideALOGLIPTIN AND METFORMIN HYDROCHLORIDEPadagis Israel Pharmaceuticals Ltd14d98490-4f8f-4d2f-a4e9-7a3d7a0199ba2026-08-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: alogliptin and metformin hydrochloride
generic name: ALOGLIPTIN AND METFORMIN HYDROCHLORIDE
KAZANOALOGLIPTIN AND METFORMIN HYDROCHLORIDETakeda Pharmaceuticals America, Inc.83cb7914-a683-47bb-a713-f2bc6a596bd22026-08-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ALOGLIPTIN AND METFORMIN HYDROCHLORIDE
alogliptin and metformin hydrochlorideALOGLIPTIN AND METFORMIN HYDROCHLORIDEA-S Medication Solutions9112d6b9-4771-4194-886d-7db887470bcc2023-10-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: alogliptin and metformin hydrochloride
generic name: ALOGLIPTIN AND METFORMIN HYDROCHLORIDE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61150ORIG2019-12-04