Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018991
Company: HOSPIRA

Products on NDA 018991

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LIPOSYN II 20%	SAFFLOWER OIL; SOYBEAN OIL	10%;10% (10GM/100ML)	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018991

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-25	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-22	Manufacturing (CMC)-Control		Label is not available on this site.
08/29/1996	SUPPL-21	Manufacturing (CMC)-Control		Label is not available on this site.
08/27/1996	SUPPL-19	Manufacturing (CMC)-Control		Label is not available on this site.
09/22/1994	SUPPL-18	Manufacturing (CMC)-Control		Label is not available on this site.
02/15/2001	SUPPL-17	Labeling		Label is not available on this site.
11/02/1990	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
01/04/1991	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
10/24/1989	SUPPL-14	Manufacturing (CMC)-Formulation		Label is not available on this site.
07/20/1989	SUPPL-13	Labeling		Label is not available on this site.
03/04/1988	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
02/22/1986	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
04/01/1986	SUPPL-8	Labeling		Label is not available on this site.
06/06/1986	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.
10/03/1985	SUPPL-2	Labeling		Label is not available on this site.
10/03/1985	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.