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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077270
Company: TEVA PHARMS
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 Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/28/2005 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077270ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/05/2017 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

08/17/2015 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

04/17/2012 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

01/19/2010 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

01/19/2010 SUPPL-4 Labeling

Label is not available on this site.

01/15/2009 SUPPL-3 Labeling

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
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
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
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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