Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 206079
Company: IMPAX LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GLYBURIDE GLYBURIDE 1.25MG TABLET;ORAL Prescription AB2 No No
GLYBURIDE GLYBURIDE 2.5MG TABLET;ORAL Prescription AB2 No No
GLYBURIDE GLYBURIDE 5MG TABLET;ORAL Prescription AB2 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
09/30/2015 ORIG-1 Approval STANDARD

Label is not available on this site.

GLYBURIDE

TABLET;ORAL; 1.25MG
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIABETA GLYBURIDE 1.25MG TABLET;ORAL Prescription Yes AB2 017532 SANOFI AVENTIS US
GLYBURIDE GLYBURIDE 1.25MG TABLET;ORAL Prescription No AB2 206079 IMPAX LABS INC

TABLET;ORAL; 2.5MG
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIABETA GLYBURIDE 2.5MG TABLET;ORAL Prescription Yes AB2 017532 SANOFI AVENTIS US
GLYBURIDE GLYBURIDE 2.5MG TABLET;ORAL Prescription No AB2 206079 IMPAX LABS INC

TABLET;ORAL; 5MG
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIABETA GLYBURIDE 5MG TABLET;ORAL Prescription Yes AB2 017532 SANOFI AVENTIS US
GLYBURIDE GLYBURIDE 5MG TABLET;ORAL Prescription No AB2 206079 IMPAX LABS INC

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