Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018991
Company: HOSPIRA
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
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.

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