Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213394
Company: AMTA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription AB2 No No
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription AB2 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
08/03/2021 ORIG-1 Approval STANDARD

Label is not available on this site.

METFORMIN HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 500MG
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 213651 AJANTA PHARMA LTD
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 213394 AMTA
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 090692 LUPIN LTD
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 200690 MYLAN PHARMS INC
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 203832 NOSTRUM LABS INC
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 209674 NOVAST LABS
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 209993 QINGDAO BAHEAL PHARM
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 213247 TWI PHARMS

TABLET, EXTENDED RELEASE;ORAL; 1GM
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FORTAMET METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB2 021574 ANDRX LABS LLC
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 213651 AJANTA PHARMA LTD
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 213394 AMTA
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 090692 LUPIN LTD
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 200690 MYLAN PHARMS INC
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 203832 NOSTRUM LABS INC
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 209674 NOVAST LABS
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 209993 QINGDAO BAHEAL PHARM
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 213247 TWI PHARMS

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