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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050640
Company: BAXTER HLTHCARE

Products on NDA 050640

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050640

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.

Labels for NDA 050640

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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