Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090937
Company: HERITAGE PHARMS
Company: HERITAGE PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GLYBURIDE | GLYBURIDE | 1.25MG | TABLET;ORAL | Prescription | AB1 | No | No |
GLYBURIDE | GLYBURIDE | 2.5MG | TABLET;ORAL | Prescription | AB1 | No | No |
GLYBURIDE | GLYBURIDE | 5MG | TABLET;ORAL | Prescription | AB1 | 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 |
---|---|---|---|---|---|---|---|
02/28/2011 | 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 |
---|---|---|---|---|---|
01/05/2016 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
02/18/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
09/27/2012 | SUPPL-3 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
08/25/2011 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
05/31/2011 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
GLYBURIDE
TABLET;ORAL; 1.25MG
TE Code = AB1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GLYBURIDE | GLYBURIDE | 1.25MG | TABLET;ORAL | Prescription | No | AB1 | 203379 | CADILA PHARMS LTD |
GLYBURIDE | GLYBURIDE | 1.25MG | TABLET;ORAL | Prescription | No | AB1 | 076257 | EPIC PHARMA LLC |
GLYBURIDE | GLYBURIDE | 1.25MG | TABLET;ORAL | Prescription | No | AB1 | 090937 | HERITAGE PHARMS |
GLYBURIDE | GLYBURIDE | 1.25MG | TABLET;ORAL | Prescription | No | AB1 | 206483 | ORIENT PHARMA CO LTD |
GLYBURIDE | GLYBURIDE | 1.25MG | TABLET;ORAL | Prescription | No | AB1 | 074388 | TEVA |
GLYBURIDE | GLYBURIDE | 1.25mg | TABLET;ORAL | Prescription | No | AB1 | 206749 | ZYDUS PHARMS |
TABLET;ORAL; 2.5MG
TE Code = AB1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GLYBURIDE | GLYBURIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB1 | 203379 | CADILA PHARMS LTD |
GLYBURIDE | GLYBURIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB1 | 076257 | EPIC PHARMA LLC |
GLYBURIDE | GLYBURIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB1 | 090937 | HERITAGE PHARMS |
GLYBURIDE | GLYBURIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB1 | 206483 | ORIENT PHARMA CO LTD |
GLYBURIDE | GLYBURIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB1 | 074388 | TEVA |
GLYBURIDE | GLYBURIDE | 2.5mg | TABLET;ORAL | Prescription | No | AB1 | 206749 | ZYDUS PHARMS |
TABLET;ORAL; 5MG
TE Code = AB1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GLYBURIDE | GLYBURIDE | 5MG | TABLET;ORAL | Prescription | No | AB1 | 203379 | CADILA PHARMS LTD |
GLYBURIDE | GLYBURIDE | 5MG | TABLET;ORAL | Prescription | No | AB1 | 076257 | EPIC PHARMA LLC |
GLYBURIDE | GLYBURIDE | 5MG | TABLET;ORAL | Prescription | No | AB1 | 090937 | HERITAGE PHARMS |
GLYBURIDE | GLYBURIDE | 5MG | TABLET;ORAL | Prescription | No | AB1 | 206483 | ORIENT PHARMA CO LTD |
GLYBURIDE | GLYBURIDE | 5MG | TABLET;ORAL | Prescription | No | AB1 | 074388 | TEVA |
GLYBURIDE | GLYBURIDE | 5MG | TABLET;ORAL | Prescription | No | AB1 | 206749 | ZYDUS PHARMS |