Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 018901
Company: HOSPIRA

Products on NDA 018901

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018901

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.