Application 210002

Type
ANDA
Sponsor
INDOCO REMEDIES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALOGLIPTINALOGLIPTIN BENZOATETABLET;ORAL6.25MGNoNo

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 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlogliptinALOGLIPTINPadagis Israel Pharmaceuticals Ltdb25f155a-1259-47c2-aa3b-7c1356e4c7f62025-04-11Warnings, Adverse reactionsName fallback
brand name: Alogliptin
AlogliptinALOGLIPTINBryant Ranch Prepackf2ad6d21-8060-42c7-8b3f-ad80085dc0222025-01-28Warnings, Adverse reactionsName fallback
brand name: Alogliptin
AlogliptinALOGLIPTINA-S Medication Solutions38d30e4f-4212-4f7a-96b5-74b277b56cba2023-10-24Warnings, Adverse reactionsName fallback
brand name: Alogliptin
AlogliptinALOGLIPTINAphena Pharma Solutions - Tennessee, LLC4b007011-547a-498e-b8f6-34ea4ea00eb42023-02-02Warnings, Adverse reactionsName fallback
brand name: Alogliptin
AlogliptinALOGLIPTINAphena Pharma Solutions - Tennessee, LLCa05d6d17-79f9-4788-a4d5-467bca1a2d912022-10-18Warnings, Adverse reactionsName fallback
brand name: Alogliptin

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61477ORIG2019-12-30