Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019681
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE 3.5%;25GM/100ML INJECTABLE;INJECTION Discontinued None No No
AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE 3.5%;5GM/100ML INJECTABLE;INJECTION Discontinued None No No
AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE 4.25%;10GM/100ML INJECTABLE;INJECTION Discontinued None No No
AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE 4.25%;20GM/100ML INJECTABLE;INJECTION Discontinued None No No
AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE 4.25%;25GM/100ML INJECTABLE;INJECTION Discontinued None No No
AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE 5%;25GM/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
11/01/1988 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
02/19/2003 SUPPL-20 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19681scs020ltr.pdf
11/08/2002 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/2002 SUPPL-18 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19681slr015,018ltr.pdf
10/29/1998 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

12/29/1998 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/2002 SUPPL-15 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19681slr015,018ltr.pdf
08/20/1997 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

06/11/1997 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

05/05/1997 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

03/04/1996 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

03/04/1997 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

08/18/1995 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/27/1996 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

07/11/1994 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/30/1993 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

09/28/1992 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/30/1991 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/28/1992 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/18/1992 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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