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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076798
Company: CHARTWELL RX

Other Important Information from FDA

Products on ANDA 076798

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076798

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/26/2012	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/076798Orig1s000TAltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/26/2018	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/26/2018	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/22/2015	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
04/22/2015	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076798

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	204133	ANNORA PHARMA
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	076798	CHARTWELL RX
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	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	210165	SHUANGCHENG
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	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	204133	ANNORA PHARMA
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	076798	CHARTWELL RX
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	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	210165	SHUANGCHENG
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	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	204133	ANNORA PHARMA
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	076798	CHARTWELL RX
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	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	210165	SHUANGCHENG
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	202456	ZYDUS PHARMS USA INC

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