Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050655
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

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