Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214874
Company: RUBICON
Company: RUBICON
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GLIPIZIDE | GLIPIZIDE | 2.5MG | TABLET;ORAL | Prescription | None | No | No |
GLIPIZIDE | GLIPIZIDE | 5MG | TABLET;ORAL | Prescription | AB | No | No |
GLIPIZIDE | GLIPIZIDE | 10MG | 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 |
---|---|---|---|---|---|---|---|
10/03/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
GLIPIZIDE
TABLET;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GLIPIZIDE | GLIPIZIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 074550 | ACCORD HLTHCARE |
GLIPIZIDE | GLIPIZIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 074497 | ANI PHARMS |
GLIPIZIDE | GLIPIZIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 075795 | APOTEX |
GLIPIZIDE | GLIPIZIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 074226 | AUROBINDO PHARMA USA |
GLIPIZIDE | GLIPIZIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 214874 | RUBICON |
GLIPIZIDE | GLIPIZIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 074305 | SANDOZ |
GLIPIZIDE | GLIPIZIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 074223 | WATSON LABS TEVA |
TABLET;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GLIPIZIDE | GLIPIZIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 074550 | ACCORD HLTHCARE |
GLIPIZIDE | GLIPIZIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 074497 | ANI PHARMS |
GLIPIZIDE | GLIPIZIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 075795 | APOTEX |
GLIPIZIDE | GLIPIZIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 074226 | AUROBINDO PHARMA USA |
GLIPIZIDE | GLIPIZIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 214874 | RUBICON |
GLIPIZIDE | GLIPIZIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 074305 | SANDOZ |
GLIPIZIDE | GLIPIZIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 074223 | WATSON LABS TEVA |