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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204133
Company: ANNORA PHARMA

Products on ANDA 204133

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 204133

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/07/2014	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
11/30/2018	SUPPL-2	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
11/30/2018	SUPPL-1	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 204133

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	078670	AIPING PHARM INC
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	210165	COREPHARMA
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	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	078670	AIPING PHARM INC
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	210165	COREPHARMA
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	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	078670	AIPING PHARM INC
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	210165	COREPHARMA
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	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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