An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 050655
Company: BAXTER HLTHCARE

Products on NDA 050655

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050655

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.

Labels for NDA 050655

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

Top