Drugs@FDA: FDA-Approved Drugs
Company: GLAXOSMITHKLINE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER | ONDANSETRON HYDROCHLORIDE | EQ 0.64MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
01/31/1995 | 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 |
---|---|---|---|---|---|
09/14/2011 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020007s042,020403s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020007s042,020403s020ltr.pdf | |
07/07/2011 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020007s041,020403s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020007s041,020403s019ltr.pdf | |
09/22/2010 | SUPPL-18 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020007s040,020403s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020007s040,020403s018ltr.pdf | |
08/22/2006 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020007s039,020403s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020007s039;020403s016ltr.pdf | |
12/27/2005 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020007s037,020403s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020403s014rev2.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020403_s014_Zofran Inj.pdf | |
11/24/2004 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20007s034,20403s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20007s034,20403s013ltr.pdf | |
11/15/2000 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/08/2000 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
12/08/2000 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
04/11/2000 | SUPPL-9 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020403_s009_ZOFRAN_INJECTION.pdf |
02/17/1999 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
03/10/1999 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
10/31/1997 | SUPPL-5 | Labeling |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20-007s022_Zofran.cfm |
04/02/1997 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
03/12/1996 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
07/26/1996 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
05/24/1996 | 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 |
---|---|---|---|---|---|
09/14/2011 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020007s042,020403s020lbl.pdf | |
07/07/2011 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020007s041,020403s019lbl.pdf | |
09/22/2010 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020007s040,020403s018lbl.pdf | |
08/22/2006 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020007s039,020403s016lbl.pdf | |
12/27/2005 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020007s037,020403s014lbl.pdf | |
11/24/2004 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20007s034,20403s013lbl.pdf |