Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065409
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFPODOXIME PROXETIL | CEFPODOXIME PROXETIL | EQ 50MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | None | No | No |
| CEFPODOXIME PROXETIL | CEFPODOXIME PROXETIL | EQ 100MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/08/2007 | 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 |
|---|---|---|---|---|---|
| 09/21/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/29/2007 | SUPPL-1 | Labeling |
Label is not available on this site. |