Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090564
Company: GRANULES INDIA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET;ORAL Prescription AB No No
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET;ORAL Prescription AB No No
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/22/2010 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
02/22/2019 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

08/14/2017 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

08/14/2017 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

04/05/2016 SUPPL-5 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

01/26/2012 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

METFORMIN HYDROCHLORIDE

TABLET;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET;ORAL Prescription No AB 091184 ALKEM
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET;ORAL Prescription No AB 077880 AMNEAL PHARMS NY
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET;ORAL Prescription No AB 075984 APOTEX
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET;ORAL Prescription No AB 090666 APOTEX
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET;ORAL Prescription No AB 076033 ATLAS PHARMS LLC
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET;ORAL Prescription No AB 077095 AUROBINDO
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET;ORAL Prescription No AB 075972 CHARTWELL LIFE SCI
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET;ORAL Prescription No AB 205096 CSPC OUYI
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET;ORAL Prescription No AB 077787 DR REDDYS LABS INC
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET;ORAL Prescription No AB 078170 GLENMARK GENERICS
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET;ORAL Prescription No AB 090564 GRANULES INDIA
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET;ORAL Prescription No AB 075978 HERITAGE PHARMA
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET;ORAL Prescription No AB 079148 INDICUS PHARMA
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET;ORAL Prescription No AB 209882 LAURUS LABS LTD
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET;ORAL Prescription No AB 205330 MACLEODS PHARMS LTD
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET;ORAL Prescription No AB 090888 MARKSANS PHARMA
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET;ORAL Prescription No AB 075973 MYLAN
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET;ORAL Prescription No AB 075976 MYLAN
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET;ORAL Prescription No AB 075965 SANDOZ
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET;ORAL Prescription No AB 203769 SCIEGEN PHARMS INC
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET;ORAL Prescription No AB 075967 SUN PHARM INDS INC
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET;ORAL Prescription No AB 077711 TORRENT PHARMS
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET;ORAL Prescription No AB 203686 ZYDUS HLTHCARE
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET;ORAL Prescription No AB 077064 ZYDUS PHARMS USA

TABLET;ORAL; 850MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET;ORAL Prescription No AB 091184 ALKEM
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET;ORAL Prescription No AB 077880 AMNEAL PHARMS NY
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET;ORAL Prescription No AB 075984 APOTEX
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET;ORAL Prescription No AB 090666 APOTEX
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET;ORAL Prescription No AB 076033 ATLAS PHARMS LLC
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET;ORAL Prescription No AB 077095 AUROBINDO
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET;ORAL Prescription No AB 075972 CHARTWELL LIFE SCI
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET;ORAL Prescription No AB 205096 CSPC OUYI
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET;ORAL Prescription No AB 077787 DR REDDYS LABS INC
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET;ORAL Prescription No AB 078170 GLENMARK GENERICS
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET;ORAL Prescription No AB 090564 GRANULES INDIA
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET;ORAL Prescription No AB 075978 HERITAGE PHARMA
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET;ORAL Prescription No AB 079148 INDICUS PHARMA
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET;ORAL Prescription No AB 209882 LAURUS LABS LTD
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET;ORAL Prescription No AB 205330 MACLEODS PHARMS LTD
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET;ORAL Prescription No AB 090888 MARKSANS PHARMA
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET;ORAL Prescription No AB 075973 MYLAN
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET;ORAL Prescription No AB 075976 MYLAN
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET;ORAL Prescription No AB 075965 SANDOZ
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET;ORAL Prescription No AB 203769 SCIEGEN PHARMS INC
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET;ORAL Prescription No AB 075967 SUN PHARM INDS INC
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET;ORAL Prescription No AB 077711 TORRENT PHARMS
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET;ORAL Prescription No AB 203686 ZYDUS HLTHCARE
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET;ORAL Prescription No AB 077064 ZYDUS PHARMS USA

TABLET;ORAL; 1GM
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET;ORAL Prescription No AB 091184 ALKEM
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET;ORAL Prescription No AB 077880 AMNEAL PHARMS NY
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET;ORAL Prescription No AB 075984 APOTEX
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET;ORAL Prescription No AB 090666 APOTEX
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET;ORAL Prescription No AB 076033 ATLAS PHARMS LLC
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET;ORAL Prescription No AB 077095 AUROBINDO
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET;ORAL Prescription No AB 075972 CHARTWELL LIFE SCI
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET;ORAL Prescription No AB 205096 CSPC OUYI
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET;ORAL Prescription No AB 077787 DR REDDYS LABS INC
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET;ORAL Prescription No AB 078170 GLENMARK GENERICS
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET;ORAL Prescription No AB 090564 GRANULES INDIA
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET;ORAL Prescription No AB 075978 HERITAGE PHARMA
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET;ORAL Prescription No AB 079148 INDICUS PHARMA
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET;ORAL Prescription No AB 209882 LAURUS LABS LTD
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET;ORAL Prescription No AB 205330 MACLEODS PHARMS LTD
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET;ORAL Prescription No AB 090888 MARKSANS PHARMA
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET;ORAL Prescription No AB 075973 MYLAN
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET;ORAL Prescription No AB 075976 MYLAN
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET;ORAL Prescription No AB 075965 SANDOZ
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET;ORAL Prescription No AB 203769 SCIEGEN PHARMS INC
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET;ORAL Prescription No AB 075967 SUN PHARM INDS INC
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET;ORAL Prescription No AB 077711 TORRENT PHARMS
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET;ORAL Prescription No AB 203686 ZYDUS HLTHCARE
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET;ORAL Prescription No AB 077064 ZYDUS PHARMS USA

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