Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076869
Company: ACTAVIS LABS FL INC
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
02/26/2019 SUPPL-26 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

02/26/2019 SUPPL-24 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

10/31/2008 SUPPL-11 Labeling

Label is not available on this site.

05/25/2007 SUPPL-4 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
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

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