Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077870
Company: AUROBINDO PHARMA
Company: AUROBINDO PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GLYBURIDE AND METFORMIN HYDROCHLORIDE | GLYBURIDE; METFORMIN HYDROCHLORIDE | 1.25MG;250MG | TABLET;ORAL | Prescription | AB | No | No |
GLYBURIDE AND METFORMIN HYDROCHLORIDE | GLYBURIDE; METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET;ORAL | Prescription | AB | No | Yes |
GLYBURIDE AND METFORMIN HYDROCHLORIDE | GLYBURIDE; 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 |
---|---|---|---|---|---|---|---|
11/14/2007 | 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 |
---|---|---|---|---|---|
02/18/2015 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
02/18/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
05/05/2010 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
03/23/2009 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
11/21/2008 | SUPPL-2 | Labeling |
Label is not available on this site. |
GLYBURIDE AND METFORMIN HYDROCHLORIDE
TABLET;ORAL; 1.25MG;250MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GLYBURIDE AND METFORMIN HYDROCHLORIDE | GLYBURIDE; METFORMIN HYDROCHLORIDE | 1.25MG;250MG | TABLET;ORAL | Prescription | No | AB | 076716 | ACTAVIS ELIZABETH |
GLYBURIDE AND METFORMIN HYDROCHLORIDE | GLYBURIDE; METFORMIN HYDROCHLORIDE | 1.25MG;250MG | TABLET;ORAL | Prescription | No | AB | 077870 | AUROBINDO PHARMA |
GLYBURIDE AND METFORMIN HYDROCHLORIDE | GLYBURIDE; METFORMIN HYDROCHLORIDE | 1.25MG;250MG | TABLET;ORAL | Prescription | No | AB | 079009 | HERITAGE PHARMS |
GLYBURIDE AND METFORMIN HYDROCHLORIDE | GLYBURIDE; METFORMIN HYDROCHLORIDE | 1.25MG;250MG | TABLET;ORAL | Prescription | No | AB | 076345 | IMPAX LABS INC |
GLYBURIDE AND METFORMIN HYDROCHLORIDE | GLYBURIDE; METFORMIN HYDROCHLORIDE | 1.25MG;250MG | TABLET;ORAL | Prescription | No | AB | 206748 | ZYDUS PHARMS |
TABLET;ORAL; 2.5MG;500MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GLYBURIDE AND METFORMIN HYDROCHLORIDE | GLYBURIDE; METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET;ORAL | Prescription | No | AB | 076716 | ACTAVIS ELIZABETH |
GLYBURIDE AND METFORMIN HYDROCHLORIDE | GLYBURIDE; METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET;ORAL | Prescription | No | AB | 077870 | AUROBINDO PHARMA |
GLYBURIDE AND METFORMIN HYDROCHLORIDE | GLYBURIDE; METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET;ORAL | Prescription | No | AB | 079009 | HERITAGE PHARMS |
GLYBURIDE AND METFORMIN HYDROCHLORIDE | GLYBURIDE; METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET;ORAL | Prescription | No | AB | 076345 | IMPAX LABS INC |
GLYBURIDE AND METFORMIN HYDROCHLORIDE | GLYBURIDE; METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET;ORAL | Prescription | No | AB | 206748 | ZYDUS PHARMS |
TABLET;ORAL; 5MG;500MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GLYBURIDE AND METFORMIN HYDROCHLORIDE | GLYBURIDE; METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET;ORAL | Prescription | No | AB | 076716 | ACTAVIS ELIZABETH |
GLYBURIDE AND METFORMIN HYDROCHLORIDE | GLYBURIDE; METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET;ORAL | Prescription | No | AB | 077870 | AUROBINDO PHARMA |
GLYBURIDE AND METFORMIN HYDROCHLORIDE | GLYBURIDE; METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET;ORAL | Prescription | No | AB | 079009 | HERITAGE PHARMS |
GLYBURIDE AND METFORMIN HYDROCHLORIDE | GLYBURIDE; METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET;ORAL | Prescription | No | AB | 076345 | IMPAX LABS INC |
GLYBURIDE AND METFORMIN HYDROCHLORIDE | GLYBURIDE; METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET;ORAL | Prescription | No | AB | 206748 | ZYDUS PHARMS |