Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077210
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET;ORAL Prescription AB No No
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription AB No No
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET;ORAL Prescription AB 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
01/10/2014 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
11/26/2018 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

11/26/2018 SUPPL-2 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

PIOGLITAZONE HYDROCHLORIDE

TABLET;ORAL; EQ 15MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACTOS PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET;ORAL Prescription Yes AB 021073 TAKEDA PHARMS USA
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET;ORAL Prescription No AB 200044 ACCORD HLTHCARE
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET;ORAL Prescription No AB 200268 AUROBINDO PHARMA LTD
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET;ORAL Prescription No AB 078472 BRECKENRIDGE
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET;ORAL Prescription No AB 076798 CELLTRION
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET;ORAL Prescription No AB 204133 LUPIN LTD
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET;ORAL Prescription No AB 202467 MACLEODS PHARMS LTD
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET;ORAL Prescription No AB 076801 MYLAN PHARMS INC
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET;ORAL Prescription No AB 078383 NEOPHARMA
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET;ORAL Prescription No AB 207806 PRINSTON INC
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET;ORAL Prescription No AB 206738 PURACAP PHARM LLC
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET;ORAL Prescription No AB 078670 SANDOZ
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET;ORAL Prescription No AB 077210 TEVA PHARMS USA
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET;ORAL Prescription No AB 091298 TORRENT PHARMS LTD
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET;ORAL Prescription No AB 202456 ZYDUS PHARMS USA INC

TABLET;ORAL; EQ 30MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACTOS PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription Yes AB 021073 TAKEDA PHARMS USA
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 200044 ACCORD HLTHCARE
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 200268 AUROBINDO PHARMA LTD
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 078472 BRECKENRIDGE
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 076798 CELLTRION
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 204133 LUPIN LTD
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 202467 MACLEODS PHARMS LTD
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 076801 MYLAN PHARMS INC
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 078383 NEOPHARMA
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 207806 PRINSTON INC
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 206738 PURACAP PHARM LLC
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 078670 SANDOZ
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 077210 TEVA PHARMS USA
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 091298 TORRENT PHARMS LTD
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 202456 ZYDUS PHARMS USA INC

TABLET;ORAL; EQ 45MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACTOS PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET;ORAL Prescription Yes AB 021073 TAKEDA PHARMS USA
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET;ORAL Prescription No AB 200044 ACCORD HLTHCARE
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET;ORAL Prescription No AB 200268 AUROBINDO PHARMA LTD
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET;ORAL Prescription No AB 078472 BRECKENRIDGE
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET;ORAL Prescription No AB 076798 CELLTRION
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET;ORAL Prescription No AB 204133 LUPIN LTD
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET;ORAL Prescription No AB 202467 MACLEODS PHARMS LTD
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET;ORAL Prescription No AB 076801 MYLAN PHARMS INC
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET;ORAL Prescription No AB 078383 NEOPHARMA
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET;ORAL Prescription No AB 207806 PRINSTON INC
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET;ORAL Prescription No AB 206738 PURACAP PHARM LLC
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET;ORAL Prescription No AB 078670 SANDOZ
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET;ORAL Prescription No AB 077210 TEVA PHARMS USA
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET;ORAL Prescription No AB 091298 TORRENT PHARMS LTD
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET;ORAL Prescription No AB 202456 ZYDUS PHARMS USA INC

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