Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 077870
Company: AUROBINDO PHARMA
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 Yes
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
11/14/2007 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/18/2015 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

02/18/2015 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

05/05/2010 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

03/23/2009 SUPPL-3 Labeling

Label is not available on this site.

11/21/2008 SUPPL-2 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 079009 HERITAGE PHARMS INC
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 079009 HERITAGE PHARMS INC
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 079009 HERITAGE PHARMS INC
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English