Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091664
Company: LUPIN 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
07/19/2013 ORIG-1 Approval Not Applicable Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/091664Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/091664Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/05/2019 SUPPL-6 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

09/05/2019 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/19/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/091664Orig1s000lbl.pdf

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 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 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 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 213334 SCIEGEN PHARMS INC
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 202917 SUN PHARM

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