Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018901
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMINESS 5.2% ESSENTIAL AMINO ACIDS W/ HISTADINE AMINO ACIDS 5.2% (5.2GM/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
04/06/1984 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
12/21/1999 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

02/09/1995 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

01/11/1993 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/25/1994 SUPPL-10 Labeling

Label is not available on this site.

07/25/1994 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

04/05/1990 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

04/05/1990 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

04/10/1989 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/23/1988 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

07/27/1984 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1985 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

12/06/1984 SUPPL-1 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

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