An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 088100
Company: HOSPIRA

Products on ANDA 088100

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HEPARIN SODIUM	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	None	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 088100

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/28/1983	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/13/2020	SUPPL-50	Labeling-Package Insert		Label is not available on this site.
05/20/2013	SUPPL-41	Labeling-Container/Carton Labels		Label is not available on this site.
05/06/2013	SUPPL-38	Labeling-Package Insert		Label is not available on this site.
05/01/2013	SUPPL-37	Labeling-Package Insert		Label is not available on this site.
12/30/2009	SUPPL-32	Labeling-Package Insert		Label is not available on this site.
05/06/2009	SUPPL-30	Labeling		Label is not available on this site.
10/23/2008	SUPPL-27	Labeling		Label is not available on this site.
02/14/2001	SUPPL-14	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
09/09/1998	SUPPL-13	Labeling		Label is not available on this site.
12/11/1996	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
12/02/1996	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
12/22/1995	SUPPL-10	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
04/06/1992	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
09/21/1992	SUPPL-7	Labeling		Label is not available on this site.
12/01/1993	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
02/15/1991	SUPPL-5	Labeling		Label is not available on this site.
06/01/1992	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
07/11/1989	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
05/08/1985	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Top