Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065130
Company: LUPIN PHARMS
Company: LUPIN PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SUPRAX | CEFIXIME | 400MG | 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 |
---|---|---|---|---|---|---|---|
02/12/2004 | 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 |
---|---|---|---|---|---|
02/16/2016 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
03/29/2013 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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01/17/2012 | SUPPL-4 | Labeling |
Label is not available on this site. |