Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050739
Company: ABBVIE
Company: ABBVIE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OMNICEF | CEFDINIR | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
12/04/1997 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050739s000_050749s000_OmnicefTOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/18/2015 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050739s017,050749s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050739Orig1s017,050749Orig1s023ltr.pdf |
12/15/2008 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050739s015,050749s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050739s015, 050749s021ltr.pdf | |
09/14/2007 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050739s014,050749s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050739s014, 050749s018ltr.pdf | |
06/15/2007 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050739s013,050749s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050739s013, 050749s017ltr.pdf | |
07/19/2005 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050739s010,050749s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050739s010,050749s013ltr.pdf | |
09/02/2004 | SUPPL-7 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50749s009,50739s007ltr.pdf |
07/24/2002 | SUPPL-6 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50739slr006ltr.pdf |
06/18/2001 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/09/2000 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
11/08/1999 | SUPPL-2 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50739S2LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50739S2LTR.PDF | |
01/13/1998 | SUPPL-1 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/18/2015 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050739s017,050749s023lbl.pdf |
12/15/2008 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050739s015,050749s021lbl.pdf | |
09/14/2007 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050739s014,050749s018lbl.pdf | |
06/15/2007 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050739s013,050749s017lbl.pdf | |
07/19/2005 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050739s010,050749s013lbl.pdf | |
11/08/1999 | SUPPL-2 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50739S2LBL.PDF |