Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090888
Company: MARKSANS PHARMA
Company: MARKSANS PHARMA
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 | 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 |
---|---|---|---|---|---|---|---|
03/12/2012 | 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-4 | Labeling-Package Insert |
Label is not available on this site. |
||
12/22/2014 | 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 | 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 |
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 | 075965 | EPIC PHARMA LLC |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET;ORAL | Prescription | No | AB | 078170 | GLENMARK PHARMS LTD |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET;ORAL | Prescription | No | AB | 090564 | GRANULES INDIA |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET;ORAL | Prescription | No | AB | 213320 | HARMAN FINOCHEM |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET;ORAL | Prescription | No | AB | 209882 | LAURUS |
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 | 203769 | SCIEGEN PHARMS INC |
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 | 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 |
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 | 075965 | EPIC PHARMA LLC |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 850MG | TABLET;ORAL | Prescription | No | AB | 078170 | GLENMARK PHARMS LTD |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 850MG | TABLET;ORAL | Prescription | No | AB | 090564 | GRANULES INDIA |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 850MG | TABLET;ORAL | Prescription | No | AB | 213320 | HARMAN FINOCHEM |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 850MG | TABLET;ORAL | Prescription | No | AB | 209882 | LAURUS |
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 | 203769 | SCIEGEN PHARMS INC |
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 | 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 |
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 | 075965 | EPIC PHARMA LLC |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET;ORAL | Prescription | No | AB | 078170 | GLENMARK PHARMS LTD |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET;ORAL | Prescription | No | AB | 090564 | GRANULES INDIA |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET;ORAL | Prescription | No | AB | 213320 | HARMAN FINOCHEM |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET;ORAL | Prescription | No | AB | 209882 | LAURUS |
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 | 203769 | SCIEGEN PHARMS INC |
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 |