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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202001
Company: TORRENT PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET;ORAL Discontinued None No No
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET;ORAL Discontinued None 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
02/13/2013 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/21/2020 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

02/21/2020 SUPPL-10 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

09/18/2015 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

09/18/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

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