An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 206749
Company: ZYDUS PHARMS

Products on ANDA 206749

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GLYBURIDE	GLYBURIDE	1.25mg	TABLET;ORAL	Prescription	AB1	No	No
GLYBURIDE	GLYBURIDE	2.5mg	TABLET;ORAL	Prescription	AB1	No	No
GLYBURIDE	GLYBURIDE	5MG	TABLET;ORAL	Prescription	AB1	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206749

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/10/2016	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 206749

GLYBURIDE

TABLET;ORAL; 1.25mg
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GLYBURIDE	GLYBURIDE	1.25MG	TABLET;ORAL	Prescription	No	AB1	203379	CADILA PHARMS LTD
GLYBURIDE	GLYBURIDE	1.25MG	TABLET;ORAL	Prescription	No	AB1	076257	EPIC PHARMA LLC
GLYBURIDE	GLYBURIDE	1.25MG	TABLET;ORAL	Prescription	No	AB1	090937	HERITAGE
GLYBURIDE	GLYBURIDE	1.25MG	TABLET;ORAL	Prescription	No	AB1	206483	ORIENT PHARMA CO LTD
GLYBURIDE	GLYBURIDE	1.25MG	TABLET;ORAL	Prescription	No	AB1	074388	TEVA
GLYBURIDE	GLYBURIDE	1.25mg	TABLET;ORAL	Prescription	No	AB1	206749	ZYDUS PHARMS

TABLET;ORAL; 2.5mg
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GLYBURIDE	GLYBURIDE	2.5MG	TABLET;ORAL	Prescription	No	AB1	203379	CADILA PHARMS LTD
GLYBURIDE	GLYBURIDE	2.5MG	TABLET;ORAL	Prescription	No	AB1	076257	EPIC PHARMA LLC
GLYBURIDE	GLYBURIDE	2.5MG	TABLET;ORAL	Prescription	No	AB1	090937	HERITAGE
GLYBURIDE	GLYBURIDE	2.5MG	TABLET;ORAL	Prescription	No	AB1	206483	ORIENT PHARMA CO LTD
GLYBURIDE	GLYBURIDE	2.5MG	TABLET;ORAL	Prescription	No	AB1	074388	TEVA
GLYBURIDE	GLYBURIDE	2.5mg	TABLET;ORAL	Prescription	No	AB1	206749	ZYDUS PHARMS

TABLET;ORAL; 5MG
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GLYBURIDE	GLYBURIDE	5MG	TABLET;ORAL	Prescription	No	AB1	203379	CADILA PHARMS LTD
GLYBURIDE	GLYBURIDE	5MG	TABLET;ORAL	Prescription	No	AB1	076257	EPIC PHARMA LLC
GLYBURIDE	GLYBURIDE	5MG	TABLET;ORAL	Prescription	No	AB1	090937	HERITAGE
GLYBURIDE	GLYBURIDE	5MG	TABLET;ORAL	Prescription	No	AB1	206483	ORIENT PHARMA CO LTD
GLYBURIDE	GLYBURIDE	5MG	TABLET;ORAL	Prescription	No	AB1	074388	TEVA
GLYBURIDE	GLYBURIDE	5MG	TABLET;ORAL	Prescription	No	AB1	206749	ZYDUS PHARMS

Top