Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076801
Company: MYLAN PHARMS INC
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
08/17/2012 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/076801Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/29/2018 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/29/2018 SUPPL-4 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

07/21/2015 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

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