Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206079
Company: IMPAX LABS INC
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. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/07/2023 | SUPPL-3 | Labeling-Package Insert |
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 |