Drugs@FDA: FDA-Approved Drugs
Company: BAXTER HLTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NALLPEN IN PLASTIC CONTAINER | NAFCILLIN SODIUM | EQ 20MG BASE/ML | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
NALLPEN IN PLASTIC CONTAINER | NAFCILLIN SODIUM | EQ 2GM BASE/100ML | 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 |
---|---|---|---|---|---|---|---|
10/31/1989 | 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 |
---|---|---|---|---|---|
04/05/2018 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050655s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050655Orig1s026ltr.pdf | |
07/14/2017 | SUPPL-25 | 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/2017/050655s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050655Orig1s025ltr.pdf |
04/03/2015 | SUPPL-23 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050655s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050655Orig1s023ltr.pdf | |
11/09/2011 | SUPPL-18 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050655s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050655s018ltr.pdf | |
04/14/2008 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050655s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050655s017ltr.pdf | |
08/09/2006 | SUPPL-16 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050655s016LTR.pdf |
08/07/2003 | SUPPL-13 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50655slr013ltr.pdf |
08/23/2002 | SUPPL-12 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50665slr012ltr.pdf |
08/07/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/05/1995 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/03/1995 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/12/1992 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
03/25/1992 | SUPPL-6 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
01/28/1992 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/17/1992 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/22/1991 | 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 |
---|---|---|---|---|---|
04/05/2018 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050655s026lbl.pdf | |
07/14/2017 | SUPPL-25 | 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/2017/050655s025lbl.pdf |
04/03/2015 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050655s023lbl.pdf | |
04/03/2015 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050655s023lbl.pdf | |
11/09/2011 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050655s018lbl.pdf | |
04/14/2008 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050655s017lbl.pdf |