Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206079
Company: IMPAX LABS INC

Products on ANDA 206079

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GLYBURIDE	GLYBURIDE	1.25MG	TABLET;ORAL	Prescription	AB2	No	No
GLYBURIDE	GLYBURIDE	2.5MG	TABLET;ORAL	Prescription	AB2	No	No
GLYBURIDE	GLYBURIDE	5MG	TABLET;ORAL	Prescription	AB2	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206079

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/30/2015	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/07/2023	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 206079

GLYBURIDE

TABLET;ORAL; 1.25MG
TE Code = AB2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIABETA	GLYBURIDE	1.25MG	TABLET;ORAL	Prescription	Yes	AB2	017532	SANOFI AVENTIS US
GLYBURIDE	GLYBURIDE	1.25MG	TABLET;ORAL	Prescription	No	AB2	206079	IMPAX LABS INC

TABLET;ORAL; 2.5MG
TE Code = AB2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIABETA	GLYBURIDE	2.5MG	TABLET;ORAL	Prescription	Yes	AB2	017532	SANOFI AVENTIS US
GLYBURIDE	GLYBURIDE	2.5MG	TABLET;ORAL	Prescription	No	AB2	206079	IMPAX LABS INC

TABLET;ORAL; 5MG
TE Code = AB2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIABETA	GLYBURIDE	5MG	TABLET;ORAL	Prescription	Yes	AB2	017532	SANOFI AVENTIS US
GLYBURIDE	GLYBURIDE	5MG	TABLET;ORAL	Prescription	No	AB2	206079	IMPAX LABS INC