Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078905
Company: ZYDUS PHARMS USA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GLIPIZIDE AND METFORMIN HYDROCHLORIDE GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET;ORAL Prescription AB No No
GLIPIZIDE AND METFORMIN HYDROCHLORIDE GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET;ORAL Prescription AB No No
GLIPIZIDE AND METFORMIN HYDROCHLORIDE GLIPIZIDE; METFORMIN HYDROCHLORIDE 5MG;500MG 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
01/31/2011 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
04/05/2017 SUPPL-3 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

06/02/2015 SUPPL-2 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

06/02/2015 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

GLIPIZIDE AND METFORMIN HYDROCHLORIDE

TABLET;ORAL; 2.5MG;250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLIPIZIDE AND METFORMIN HYDROCHLORIDE GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET;ORAL Prescription No AB 077507 EPIC PHARMA LLC
GLIPIZIDE AND METFORMIN HYDROCHLORIDE GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET;ORAL Prescription No AB 078728 HERITAGE PHARMS INC
GLIPIZIDE AND METFORMIN HYDROCHLORIDE GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET;ORAL Prescription No AB 077620 SUN PHARM INDS INC
GLIPIZIDE AND METFORMIN HYDROCHLORIDE GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET;ORAL Prescription No AB 077270 TEVA PHARMS
GLIPIZIDE AND METFORMIN HYDROCHLORIDE GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET;ORAL Prescription No AB 078905 ZYDUS PHARMS USA INC

TABLET;ORAL; 2.5MG;500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLIPIZIDE AND METFORMIN HYDROCHLORIDE GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET;ORAL Prescription No AB 077507 EPIC PHARMA LLC
GLIPIZIDE AND METFORMIN HYDROCHLORIDE GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET;ORAL Prescription No AB 078728 HERITAGE PHARMS INC
GLIPIZIDE AND METFORMIN HYDROCHLORIDE GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET;ORAL Prescription No AB 078083 MYLAN
GLIPIZIDE AND METFORMIN HYDROCHLORIDE GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET;ORAL Prescription No AB 077620 SUN PHARM INDS INC
GLIPIZIDE AND METFORMIN HYDROCHLORIDE GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET;ORAL Prescription No AB 077270 TEVA PHARMS
GLIPIZIDE AND METFORMIN HYDROCHLORIDE GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET;ORAL Prescription No AB 078905 ZYDUS PHARMS USA INC

TABLET;ORAL; 5MG;500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLIPIZIDE AND METFORMIN HYDROCHLORIDE GLIPIZIDE; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET;ORAL Prescription No AB 077507 EPIC PHARMA LLC
GLIPIZIDE AND METFORMIN HYDROCHLORIDE GLIPIZIDE; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET;ORAL Prescription No AB 078728 HERITAGE PHARMS INC
GLIPIZIDE AND METFORMIN HYDROCHLORIDE GLIPIZIDE; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET;ORAL Prescription No AB 078083 MYLAN
GLIPIZIDE AND METFORMIN HYDROCHLORIDE GLIPIZIDE; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET;ORAL Prescription No AB 077620 SUN PHARM INDS INC
GLIPIZIDE AND METFORMIN HYDROCHLORIDE GLIPIZIDE; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET;ORAL Prescription No AB 077270 TEVA PHARMS
GLIPIZIDE AND METFORMIN HYDROCHLORIDE GLIPIZIDE; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET;ORAL Prescription No AB 078905 ZYDUS PHARMS USA INC

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