Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202467
Company: MACLEODS 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 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
02/06/2013 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202467Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/17/2018 SUPPL-12 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/17/2018 SUPPL-9 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/26/2016 SUPPL-4 Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Patient Package Insert

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 PHARM
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 PHARM
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 PHARM
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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