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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050638
Company: BAXTER HLTHCARE

Products on NDA 050638

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	PENICILLIN G POTASSIUM	20,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	None	Yes	Yes
PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	PENICILLIN G POTASSIUM	40,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	None	Yes	Yes
PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	PENICILLIN G POTASSIUM	60,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050638

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/25/1990	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
11/02/2023	SUPPL-21	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050638s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/050638Orig1s021ltr.pdf
11/27/2017	SUPPL-20	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/2017/050638s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050638Orig1s020ltr.pdf
07/18/2016	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050638s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050638Orig1s019ltr.pdf
03/19/2014	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
04/16/2012	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050638s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050638s016ltr.pdf
03/01/2008	SUPPL-12	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050638s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050638s012ltr.pdf
02/04/2005	SUPPL-11	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50638s011ltr.pdf
06/10/2004	SUPPL-10	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50638slr010ltr.pdf
11/07/2000	SUPPL-8	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/23/2002	SUPPL-7	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50638slr007ltr.pdf
07/20/1999	SUPPL-6	Labeling		Label is not available on this site.
10/31/1994	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
11/19/1991	SUPPL-2	Labeling		Label is not available on this site.
11/03/1992	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 050638

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/02/2023	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050638s021lbl.pdf
11/02/2023	SUPPL-21	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050638s021lbl.pdf
11/27/2017	SUPPL-20	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/2017/050638s020lbl.pdf
07/18/2016	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050638s019lbl.pdf
04/16/2012	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050638s016lbl.pdf
03/01/2008	SUPPL-12	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050638s012lbl.pdf

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