Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206928
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GLIPIZIDE | GLIPIZIDE | 2.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| GLIPIZIDE | GLIPIZIDE | 5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| GLIPIZIDE | GLIPIZIDE | 10MG | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 05/12/2017 | 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 |
|---|---|---|---|---|---|
| 10/11/2019 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/11/2019 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
GLIPIZIDE
TABLET, EXTENDED RELEASE;ORAL; 2.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GLIPIZIDE | GLIPIZIDE | 2.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206928 | AUROBINDO PHARMA LTD |
| GLIPIZIDE | GLIPIZIDE | 2.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204720 | UNIQUE PHARM LABS |
| GLIPIZIDE | GLIPIZIDE | 2.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076467 | WATSON LABS |
| GLIPIZIDE | GLIPIZIDE | 2.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203499 | ZYDUS PHARMS |
| GLUCOTROL XL | GLIPIZIDE | 2.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020329 | PFIZER |
TABLET, EXTENDED RELEASE;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, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206928 | AUROBINDO PHARMA LTD |
| GLIPIZIDE | GLIPIZIDE | 5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204720 | UNIQUE PHARM LABS |
| GLIPIZIDE | GLIPIZIDE | 5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076467 | WATSON LABS |
| GLIPIZIDE | GLIPIZIDE | 5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203499 | ZYDUS PHARMS |
| GLUCOTROL XL | GLIPIZIDE | 5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020329 | PFIZER |
TABLET, EXTENDED RELEASE;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, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206928 | AUROBINDO PHARMA LTD |
| GLIPIZIDE | GLIPIZIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204720 | UNIQUE PHARM LABS |
| GLIPIZIDE | GLIPIZIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076467 | WATSON LABS |
| GLIPIZIDE | GLIPIZIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203499 | ZYDUS PHARMS |
| GLUCOTROL XL | GLIPIZIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020329 | PFIZER |
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