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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019805
Company: HOSPIRA

Products on NDA 019805

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	HEPARIN SODIUM	4,000 UNITS/100ML	INJECTABLE;INJECTION	Discontinued	None	No	No
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	HEPARIN SODIUM	5,000 UNITS/100ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019805

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/25/1989	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019085Orig1s000rev.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/01/2019	SUPPL-42	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019805s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019805Orig1s042ltr.pdf
03/13/2014	SUPPL-36	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019805s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019805Orig1s036ltr.pdf
09/04/2019	SUPPL-34	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018916s063,019339s052,019805s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018916Orig1s063, 019339Orig1s052, 019805Orig1s034ltr.pdf
02/08/2013	SUPPL-32	Manufacturing (CMC)		Label is not available on this site.
12/23/2011	SUPPL-29	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019805s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019805s029ltr.pdf
09/18/2002	SUPPL-15	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
03/16/2000	SUPPL-14	Labeling		Label is not available on this site.
11/25/1997	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
05/27/1998	SUPPL-12	Labeling		Label is not available on this site.
08/29/1996	SUPPL-11	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/24/1995	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
09/05/1996	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
08/30/1996	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
02/25/1992	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
02/18/1992	SUPPL-5	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/16/1990	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
02/16/1990	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 019805

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/04/2019	SUPPL-34	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018916s063,019339s052,019805s034lbl.pdf
08/01/2019	SUPPL-42	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019805s042lbl.pdf
03/13/2014	SUPPL-36	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019805s036lbl.pdf
12/23/2011	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019805s029lbl.pdf

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