Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050640
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BACTOCILL IN PLASTIC CONTAINER OXACILLIN SODIUM EQ 20MG BASE/ML INJECTABLE;INJECTION Prescription None Yes Yes
BACTOCILL IN PLASTIC CONTAINER OXACILLIN SODIUM EQ 40MG BASE/ML 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
10/26/1989 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
02/24/2017 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050640s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050640Orig1s020ltr.pdf
01/06/2015 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050640s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050640Orig1s017ltr.pdf
11/21/2012 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050640s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050640Orig1s015ltr.pdf
04/19/2013 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/13/2011 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050640s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050640s011ltr.pdf
04/17/2008 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050640s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050640s010ltr.pdf
02/19/2014 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/17/2004 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50640slr007ltr.pdf
08/23/2002 SUPPL-6 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50640slr006ltr.pdf
02/02/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/12/2000 SUPPL-4 Labeling

Label is not available on this site.

04/05/1993 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

12/19/1991 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
02/24/2017 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050640s020lbl.pdf
01/06/2015 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050640s017lbl.pdf
11/21/2012 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050640s015lbl.pdf
10/13/2011 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050640s011lbl.pdf
04/17/2008 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050640s010lbl.pdf

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