Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017957
Company: HOSPIRA INC

Products on NDA 017957

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NOVAMINE 11.4%	AMINO ACIDS	11.4% (11.4GM/100ML)	INJECTABLE;INJECTION	Discontinued	None	No	No
NOVAMINE 15%	AMINO ACIDS	15% (75GM/500ML)	INJECTABLE;INJECTION	Discontinued	None	No	No
NOVAMINE 8.5%	AMINO ACIDS	8.5% (8.5GM/100ML)	INJECTABLE;INJECTION	Discontinued	None	No	No
VEINAMINE 8%	AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE	8%;61MG/100ML;211MG/100ML;56MG/100ML;388MG/100ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017957

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/03/1978	ORIG-1	Approval	Type 3 - New Dosage Form	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
01/12/2005	SUPPL-39	Manufacturing (CMC)-Control	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/17957s039ltr.pdf
12/21/1999	SUPPL-36	Manufacturing (CMC)-Control		Label is not available on this site.
02/09/1995	SUPPL-35	Manufacturing (CMC)		Label is not available on this site.
01/11/1993	SUPPL-34	Manufacturing (CMC)		Label is not available on this site.
04/28/1993	SUPPL-33	Manufacturing (CMC)-Control		Label is not available on this site.
04/17/2003	SUPPL-32	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17957slr032ltr.pdf
04/05/1990	SUPPL-30	Manufacturing (CMC)-Control		Label is not available on this site.
04/05/1990	SUPPL-29	Manufacturing (CMC)-Control		Label is not available on this site.
04/10/1989	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.
09/17/1987	SUPPL-27	Manufacturing (CMC)-Control		Label is not available on this site.
04/30/1987	SUPPL-26	Labeling		Label is not available on this site.
03/26/1987	SUPPL-25	Manufacturing (CMC)-Control		Label is not available on this site.
04/04/1986	SUPPL-24	Manufacturing (CMC)-Control		Label is not available on this site.
11/28/1986	SUPPL-23	Manufacturing (CMC)-Control		Label is not available on this site.
11/28/1986	SUPPL-22	Labeling		Label is not available on this site.
04/23/1985	SUPPL-21	Labeling		Label is not available on this site.
04/23/1985	SUPPL-20	Manufacturing (CMC)-Control		Label is not available on this site.
07/27/1984	SUPPL-19	Manufacturing (CMC)-Control		Label is not available on this site.
11/01/1985	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
01/19/1984	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
06/22/1983	SUPPL-14	Labeling		Label is not available on this site.
06/07/1983	SUPPL-13	Labeling		Label is not available on this site.
08/09/1982	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
05/05/1982	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
08/09/1982	SUPPL-10	Labeling		Label is not available on this site.
07/08/1981	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
06/17/1981	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
05/09/1979	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
04/09/1979	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
03/26/1979	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.