Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065083
Company: SUN PHARM INDS LTD
Company: SUN PHARM INDS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CEFPODOXIME PROXETIL | CEFPODOXIME PROXETIL | EQ 100MG BASE | TABLET;ORAL | Discontinued | None | No | No |
CEFPODOXIME PROXETIL | CEFPODOXIME PROXETIL | EQ 200MG BASE | TABLET;ORAL | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
08/20/2003 | 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 |
---|---|---|---|---|---|
04/25/2008 | SUPPL-10 | Labeling |
Label is not available on this site. |
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07/12/2004 | SUPPL-2 | Labeling |
Label is not available on this site. |