Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204802
Company: MACLEODS PHARMS LTD

Products on ANDA 204802

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	Prescription	AB	No	No
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204802

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/05/2015	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204802Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/13/2025	SUPPL-36	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/13/2025	SUPPL-27	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/07/2023	SUPPL-24	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
03/06/2019	SUPPL-8	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
03/06/2019	SUPPL-5	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/14/2016	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 204802

PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE

TABLET;ORAL; 500MG;EQ 15MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET;ORAL	Prescription	No	AB	200823	AUROBINDO PHARMA LTD
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET;ORAL	Prescription	No	AB	204802	MACLEODS PHARMS LTD
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET;ORAL	Prescription	No	AB	091155	TEVA PHARMS USA
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET;ORAL	Prescription	No	AB	202001	TORRENT PHARMS LTD

TABLET;ORAL; 850MG;EQ 15MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACTOPLUS MET	METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET;ORAL	Prescription	Yes	AB	021842	TAKEDA PHARMS USA
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET;ORAL	Prescription	No	AB	200823	AUROBINDO PHARMA LTD
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET;ORAL	Prescription	No	AB	204802	MACLEODS PHARMS LTD
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET;ORAL	Prescription	No	AB	091155	TEVA PHARMS USA
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET;ORAL	Prescription	No	AB	202001	TORRENT PHARMS LTD