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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019681
Company: HOSPIRA

Products on NDA 019681

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019681

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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