Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065129
Company: LUPIN PHARMS
Company: LUPIN PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SUPRAX | CEFIXIME | 100MG/5ML | FOR SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 02/23/2004 | 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 |
|---|---|---|---|---|---|
| 06/04/2018 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/13/2016 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/29/2013 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/25/2009 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 10/06/2005 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 12/09/2004 | SUPPL-3 | Labeling |
Label is not available on this site. |