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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091298
Company: TORRENT PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET;ORAL Discontinued None No No
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Discontinued None No No
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 45MG 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

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/27/2018 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

11/27/2018 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

07/27/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

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