Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203965
Company: ORIENT PHARMA CO LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MIGLITOL MIGLITOL 25MG TABLET;ORAL Prescription AB No No
MIGLITOL MIGLITOL 50MG TABLET;ORAL Prescription AB No No
MIGLITOL MIGLITOL 100MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/24/2015 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203965Orig1s000ltr.pdf

MIGLITOL

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLYSET MIGLITOL 25MG TABLET;ORAL Prescription Yes AB 020682 PFIZER
MIGLITOL MIGLITOL 25MG TABLET;ORAL Prescription No AB 203965 ORIENT PHARMA CO LTD

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLYSET MIGLITOL 50MG TABLET;ORAL Prescription Yes AB 020682 PFIZER
MIGLITOL MIGLITOL 50MG TABLET;ORAL Prescription No AB 203965 ORIENT PHARMA CO LTD

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLYSET MIGLITOL 100MG TABLET;ORAL Prescription Yes AB 020682 PFIZER
MIGLITOL MIGLITOL 100MG TABLET;ORAL Prescription No AB 203965 ORIENT PHARMA CO LTD

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