Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075890
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GLYBURIDE (MICRONIZED) GLYBURIDE 1.5MG TABLET;ORAL Prescription AB No No
GLYBURIDE (MICRONIZED) GLYBURIDE 3MG TABLET;ORAL Prescription AB No No
GLYBURIDE (MICRONIZED) GLYBURIDE 6MG 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
07/31/2003 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75890.ta.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/05/2016 SUPPL-8 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

01/05/2016 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

04/13/2015 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

04/13/2015 SUPPL-5 Labeling-Container/Carton Labels

Label is not available on this site.

04/13/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

08/29/2011 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

03/12/2009 SUPPL-2 Labeling

Label is not available on this site.

GLYBURIDE (MICRONIZED)

TABLET;ORAL; 1.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLYBURIDE (MICRONIZED) GLYBURIDE 1.5MG TABLET;ORAL Prescription No AB 074591 DAVA PHARMS INC
GLYBURIDE (MICRONIZED) GLYBURIDE 1.5MG TABLET;ORAL Prescription No AB 075890 HIKMA
GLYBURIDE (MICRONIZED) GLYBURIDE 1.5MG TABLET;ORAL Prescription No AB 074792 MYLAN
GLYBURIDE (MICRONIZED) GLYBURIDE 1.5MG TABLET;ORAL Prescription No AB 074686 TEVA
GLYNASE GLYBURIDE 1.5MG TABLET;ORAL Prescription Yes AB 020051 PHARMACIA AND UPJOHN

TABLET;ORAL; 3MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLYBURIDE (MICRONIZED) GLYBURIDE 3MG TABLET;ORAL Prescription No AB 074591 DAVA PHARMS INC
GLYBURIDE (MICRONIZED) GLYBURIDE 3MG TABLET;ORAL Prescription No AB 075890 HIKMA
GLYBURIDE (MICRONIZED) GLYBURIDE 3MG TABLET;ORAL Prescription No AB 074792 MYLAN
GLYBURIDE (MICRONIZED) GLYBURIDE 3MG TABLET;ORAL Prescription No AB 074686 TEVA
GLYNASE GLYBURIDE 3MG TABLET;ORAL Prescription Yes AB 020051 PHARMACIA AND UPJOHN

TABLET;ORAL; 6MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLYBURIDE (MICRONIZED) GLYBURIDE 6MG TABLET;ORAL Prescription No AB 074591 DAVA PHARMS INC
GLYBURIDE (MICRONIZED) GLYBURIDE 6MG TABLET;ORAL Prescription No AB 075890 HIKMA
GLYBURIDE (MICRONIZED) GLYBURIDE 6MG TABLET;ORAL Prescription No AB 074792 MYLAN
GLYBURIDE (MICRONIZED) GLYBURIDE 6MG TABLET;ORAL Prescription No AB 074686 TEVA
GLYNASE GLYBURIDE 6MG TABLET;ORAL Prescription Yes AB 020051 PHARMACIA AND UPJOHN

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