Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076345
Company: IMPAX LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GLYBURIDE AND METFORMIN HYDROCHLORIDE GLYBURIDE; METFORMIN HYDROCHLORIDE 1.25MG;250MG TABLET;ORAL Prescription AB No No
GLYBURIDE AND METFORMIN HYDROCHLORIDE GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET;ORAL Prescription AB No No
GLYBURIDE AND METFORMIN HYDROCHLORIDE GLYBURIDE; METFORMIN HYDROCHLORIDE 5MG;500MG 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
02/18/2004 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76345ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/08/2015 SUPPL-32 Labeling-Package Insert

Label is not available on this site.

09/27/2011 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

04/27/2010 SUPPL-29 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

02/04/2014 SUPPL-26 Labeling

Label is not available on this site.

03/16/2009 SUPPL-23 Labeling

Label is not available on this site.

12/05/2008 SUPPL-22 Labeling

Label is not available on this site.

04/08/2015 SUPPL-19 Labeling

Label is not available on this site.

07/27/2007 SUPPL-16 Labeling

Label is not available on this site.

11/21/2007 SUPPL-13 Labeling

Label is not available on this site.

03/02/2006 SUPPL-7 Labeling

Label is not available on this site.

07/26/2005 SUPPL-5 Labeling

Label is not available on this site.

GLYBURIDE AND METFORMIN HYDROCHLORIDE

TABLET;ORAL; 1.25MG;250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLYBURIDE AND METFORMIN HYDROCHLORIDE GLYBURIDE; METFORMIN HYDROCHLORIDE 1.25MG;250MG TABLET;ORAL Prescription No AB 076716 ACTAVIS ELIZABETH
GLYBURIDE AND METFORMIN HYDROCHLORIDE GLYBURIDE; METFORMIN HYDROCHLORIDE 1.25MG;250MG TABLET;ORAL Prescription No AB 077870 AUROBINDO PHARMA
GLYBURIDE AND METFORMIN HYDROCHLORIDE GLYBURIDE; METFORMIN HYDROCHLORIDE 1.25MG;250MG TABLET;ORAL Prescription No AB 076345 IMPAX LABS INC
GLYBURIDE AND METFORMIN HYDROCHLORIDE GLYBURIDE; METFORMIN HYDROCHLORIDE 1.25MG;250MG TABLET;ORAL Prescription No AB 206748 ZYDUS PHARMS

TABLET;ORAL; 2.5MG;500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLYBURIDE AND METFORMIN HYDROCHLORIDE GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET;ORAL Prescription No AB 076716 ACTAVIS ELIZABETH
GLYBURIDE AND METFORMIN HYDROCHLORIDE GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET;ORAL Prescription No AB 077870 AUROBINDO PHARMA
GLYBURIDE AND METFORMIN HYDROCHLORIDE GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET;ORAL Prescription No AB 076345 IMPAX LABS INC
GLYBURIDE AND METFORMIN HYDROCHLORIDE GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET;ORAL Prescription No AB 206748 ZYDUS PHARMS

TABLET;ORAL; 5MG;500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLYBURIDE AND METFORMIN HYDROCHLORIDE GLYBURIDE; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET;ORAL Prescription No AB 076716 ACTAVIS ELIZABETH
GLYBURIDE AND METFORMIN HYDROCHLORIDE GLYBURIDE; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET;ORAL Prescription No AB 077870 AUROBINDO PHARMA
GLYBURIDE AND METFORMIN HYDROCHLORIDE GLYBURIDE; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET;ORAL Prescription No AB 076345 IMPAX LABS INC
GLYBURIDE AND METFORMIN HYDROCHLORIDE GLYBURIDE; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET;ORAL Prescription No AB 206748 ZYDUS PHARMS

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