An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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
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-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/06/2019	SUPPL-5	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/14/2016	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		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

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

Top