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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213962
Company: AJANTA PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription AB3 No No
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription AB3 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
03/09/2021 ORIG-1 Approval STANDARD

Label is not available on this site.

METFORMIN HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 500MG
TE Code = AB3

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLUMETZA METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB3 021748 SANTARUS INC
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 203755 ACTAVIS LABS FL INC
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 213962 AJANTA PHARMA LTD
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 213356 APOTEX
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 212969 GLENMARK PHARMS LTD
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 213344 GRANULES
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 091664 LUPIN LTD
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 212448 MICRO LABS
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 212681 PRINSTON INC
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 215629 RK PHARMA
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 213334 SCIEGEN PHARMS INC
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 202917 SUN PHARM

TABLET, EXTENDED RELEASE;ORAL; 1GM
TE Code = AB3

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLUMETZA METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB3 021748 SANTARUS INC
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 203755 ACTAVIS LABS FL INC
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 213962 AJANTA PHARMA LTD
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 213356 APOTEX
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 212969 GLENMARK PHARMS LTD
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 213344 GRANULES
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 091664 LUPIN LTD
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 212448 MICRO LABS
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 212681 PRINSTON INC
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 215629 RK PHARMA
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 213334 SCIEGEN PHARMS INC
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 202917 SUN PHARM
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