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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201049
Company: SANDOZ

Products on ANDA 201049

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE	GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE	2MG;30MG	TABLET;ORAL	Prescription	AB	No	No
PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE	GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE	4MG;30MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201049

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/04/2013	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/24/2020	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/24/2020	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/23/2015	SUPPL-5	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
07/23/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
06/02/2015	SUPPL-1	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 201049

PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE

TABLET;ORAL; 2MG;30MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DUETACT	GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE	2MG;30MG	TABLET;ORAL	Prescription	Yes	AB	021925	TAKEDA PHARMS USA
PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE	GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE	2MG;30MG	TABLET;ORAL	Prescription	No	AB	201049	SANDOZ

TABLET;ORAL; 4MG;30MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DUETACT	GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE	4MG;30MG	TABLET;ORAL	Prescription	Yes	AB	021925	TAKEDA PHARMS USA
PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE	GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE	4MG;30MG	TABLET;ORAL	Prescription	No	AB	201049	SANDOZ

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