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Generated: December 9, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203965

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NDA 203965 describes MIGLITOL, which is a drug marketed by Orient Pharma Co Ltd and is included in one NDA. It is available from two suppliers. Additional details are available on the MIGLITOL profile page.

The generic ingredient in MIGLITOL is miglitol. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the miglitol profile page.
Summary for 203965
Tradename:MIGLITOL
Applicant:Orient Pharma Co Ltd
Ingredient:miglitol
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203965
Mechanism of Actionalpha Glucosidase Inhibitors
Suppliers and Packaging for NDA: 203965
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIGLITOL miglitol TABLET;ORAL 203965 ANDA Sun Pharmaceutical Industries Ltd. 57664-684 57664-684-88 100 TABLET, COATED in 1 BOTTLE (57664-684-88)
MIGLITOL miglitol TABLET;ORAL 203965 ANDA Sun Pharmaceutical Industries Ltd. 57664-685 57664-685-88 100 TABLET, COATED in 1 BOTTLE (57664-685-88)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Feb 24, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Feb 24, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Feb 24, 2015TE:ABRLD:No

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