Drugs@FDA: FDA-Approved Drugs
Company: LEDERLE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SUPRAX | CEFIXIME | 100MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
04/28/1989 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
---|---|---|---|---|---|
05/18/2004 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
08/20/2003 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50621slr026,50622slr020_suprax_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50621slr026,50622slr020ltr.pdf | |
08/06/2002 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/29/2004 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50621slr023,50622slr017_suprax_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50621slr023,50622slr017ltr.pdf | |
03/15/2001 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/13/2009 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
02/06/2001 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
02/27/1998 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
03/09/1994 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/22/1993 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
03/13/2009 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
09/10/1992 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/13/2009 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
03/09/1992 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
12/05/1991 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/19/1993 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
06/25/1991 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/13/2009 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
03/30/1990 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/31/1989 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/29/2004 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50621slr023,50622slr017_suprax_lbl.pdf | |
08/20/2003 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50621slr026,50622slr020_suprax_lbl.pdf |