Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203965
Company: ORIENT PHARMA

Products on ANDA 203965

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MIGLITOL	MIGLITOL	25MG	TABLET;ORAL	Prescription	AB	No	Yes
MIGLITOL	MIGLITOL	50MG	TABLET;ORAL	Prescription	AB	No	No
MIGLITOL	MIGLITOL	100MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203965

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

Therapeutic Equivalents for ANDA 203965

MIGLITOL

TABLET;ORAL; 25MG
TE Code = AB

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

TABLET;ORAL; 50MG
TE Code = AB

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

TABLET;ORAL; 100MG
TE Code = AB

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