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

New Drug Application (NDA): 018997
Company: HOSPIRA

Products on NDA 018997

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LIPOSYN II 10%	SAFFLOWER OIL; SOYBEAN OIL	5%;5% (5GM/100ML)	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018997

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/27/1984	ORIG-1	Approval	Type 4 - New Combination	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
04/14/2003	SUPPL-26	Manufacturing (CMC)-Control	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18991scs025,18997scs026ltr.pdf
11/17/1997	SUPPL-23	Manufacturing (CMC)-Control		Label is not available on this site.
08/29/1996	SUPPL-22	Manufacturing (CMC)-Control		Label is not available on this site.
08/27/1996	SUPPL-20	Manufacturing (CMC)-Control		Label is not available on this site.
09/22/1994	SUPPL-19	Manufacturing (CMC)-Control		Label is not available on this site.
02/15/2001	SUPPL-18	Labeling		Label is not available on this site.
11/02/1990	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
01/04/1991	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
10/24/1989	SUPPL-15	Manufacturing (CMC)-Formulation		Label is not available on this site.
07/20/1989	SUPPL-14	Labeling		Label is not available on this site.
02/22/1986	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
04/01/1986	SUPPL-9	Labeling		Label is not available on this site.
06/06/1986	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
07/24/1986	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
04/02/1986	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
09/12/1985	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
01/26/1985	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
10/17/1985	SUPPL-2	Labeling		Label is not available on this site.
10/17/1985	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.

Top