Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076864
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE;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
04/12/2005 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
03/01/2019 SUPPL-16 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

03/01/2019 SUPPL-15 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

10/22/2010 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

04/27/2010 SUPPL-9 Labeling

Label is not available on this site.

12/13/2011 SUPPL-6 Labeling

Label is not available on this site.

04/18/2007 SUPPL-4 Labeling

Label is not available on this site.

01/03/2007 SUPPL-3 Labeling

Label is not available on this site.

METFORMIN HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 750MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLUCOPHAGE XR METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021202 BRISTOL MYERS SQUIBB
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076869 ACTAVIS LABS FL INC
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206145 ALKEM LABS LTD
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078596 AMNEAL PHARMS NY
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076706 APOTEX
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 079118 AUROBINDO PHARMA LTD
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076863 BARR
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207427 BEXIMCO PHARMS USA
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 077078 CADILA
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078321 CSPC OUYI
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209313 GRANULES INDIA LTD
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202306 INTELLIPHARMACEUTICS
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206955 MACLEODS PHARMS LTD
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090295 MARKSANS PHARMA
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076756 NOSTRUM PHARMS LLC
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 208880 PRINSTON INC
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 077336 SUN PHARM INDS (IN)
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076864 TEVA

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