Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 201049
Company: SANDOZ
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
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
07/23/2015 SUPPL-5 Labeling-Medication Guide, Labeling-Package Insert

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.

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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