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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019953
Company: B BRAUN

Products on NDA 019953

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	HEPARIN SODIUM	200 UNITS/100ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	HEPARIN SODIUM	200 UNITS/100ML	INJECTABLE;INJECTION	Prescription	None	Yes	Yes
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	HEPARIN SODIUM	5,000 UNITS/100ML	INJECTABLE;INJECTION	Prescription	None	Yes	Yes
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	HEPARIN SODIUM	10,000 UNITS/100ML	INJECTABLE;INJECTION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019953

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/20/1992	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	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
03/25/2025	SUPPL-48	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019953s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/019953Orig1s048ltr.pdf
12/15/2023	SUPPL-44	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019953s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019953Orig1s044ltr.pdf
05/12/2016	SUPPL-32	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019953s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019953Orig1s032ltr.pdf
08/30/2013	SUPPL-30	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019953s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019953Orig1s030ltr.pdf
01/10/2013	SUPPL-29	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019953s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019953Orig1s029ltr.pdf
12/27/2011	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019953s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019953s025ltr.pdf
02/26/2009	SUPPL-21	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019953s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019953s021ltr.pdf
08/22/2014	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
04/13/2004	SUPPL-12	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/019953slr012ltr.pdf
07/12/2002	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
02/15/2002	SUPPL-9	Manufacturing (CMC)-Packaging		Label is not available on this site.
11/22/2000	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
03/01/2000	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
06/05/1998	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
07/30/1996	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
03/09/1995	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
12/22/1992	SUPPL-3	Labeling		Label is not available on this site.
12/02/1992	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
03/29/1993	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.

Labels for NDA 019953

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/25/2025	SUPPL-48	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019953s048lbl.pdf
12/15/2023	SUPPL-44	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019953s044lbl.pdf
05/12/2016	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019953s032lbl.pdf
08/30/2013	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019953s030lbl.pdf
08/30/2013	SUPPL-30	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019953s030lbl.pdf
01/10/2013	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019953s029lbl.pdf
12/27/2011	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019953s025lbl.pdf
02/26/2009	SUPPL-21	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019953s021lbl.pdf

Therapeutic Equivalents for NDA 019953

HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 200 UNITS/100ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	HEPARIN SODIUM	200 UNITS/100ML	INJECTABLE;INJECTION	Prescription	No	AP	018609	BAXTER HLTHCARE
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	HEPARIN SODIUM	200 UNITS/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	019953	B BRAUN
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	HEPARIN SODIUM	200 UNITS/100ML	INJECTABLE;INJECTION	Prescription	No	AP	212441	FRESENIUS KABI USA
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	HEPARIN SODIUM	200 UNITS/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	018916	HOSPIRA
HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	HEPARIN SODIUM	200 UNITS/100ML	INJECTABLE;INJECTION	Prescription	No	AP	018609	BAXTER HLTHCARE
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	HEPARIN SODIUM	200 UNITS/100ML	INJECTABLE;INJECTION	Prescription	No	AP	212441	FRESENIUS KABI USA
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	HEPARIN SODIUM	200 UNITS/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	018916	HOSPIRA

HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

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