Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090406
Company: MYLAN
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
02/25/2011 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/090406Orig1s000Approv.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/22/2019 SUPPL-8 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

02/22/2019 SUPPL-7 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/22/2019 SUPPL-6 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

05/01/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

05/01/2015 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

11/29/2011 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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