Drugs@FDA: FDA Approved Drug Products
New Drug Application (NDA): 050671
Company: BAXTER HLTHCARE
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/100ML | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
| VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER | VANCOMYCIN HYDROCHLORIDE | EQ 750MG BASE/150ML | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
| VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/200ML | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/29/1993 | 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 |
|---|---|---|---|---|---|
| 09/28/2017 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050671s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050671Orig1s024ltr.pdf | |
| 01/09/2017 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050671s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050671Orig1s023ltr.pdf | |
| 12/18/2015 | SUPPL-22 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050671s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050671Orig1s022ltr.pdf | |
| 11/13/2015 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/17/2012 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050671s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050671s018ltr.pdf | |
| 03/11/2009 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050671s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050671s014ltr.pdf | |
| 05/02/2008 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050671s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050671s012ltr.pdf | |
| 09/17/2007 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050671s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050671s010ltr.pdf | |
| 03/30/2004 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50671slr006_vancocin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50671slr006ltr.pdf | |
| 03/01/1999 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/08/1998 | SUPPL-4 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050671s002_vancocin.pdf |
| 11/07/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/08/1998 | SUPPL-2 | Efficacy-New Patient Population |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050671s002_vancocin.pdf |
| 07/30/1996 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/28/2017 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050671s024lbl.pdf | |
| 01/09/2017 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050671s023lbl.pdf | |
| 12/18/2015 | SUPPL-22 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050671s022lbl.pdf |
| 01/17/2012 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050671s018lbl.pdf | |
| 03/11/2009 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050671s014lbl.pdf | |
| 05/02/2008 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050671s012lbl.pdf | |
| 09/17/2007 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050671s010lbl.pdf | |
| 03/30/2004 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50671slr006_vancocin_lbl.pdf |
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