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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021643
Company: HOSPIRA

Products on NDA 021643

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
M.V.I. ADULT (PHARMACY BULK PACKAGE)	ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E; VITAMIN K	200MG/5ML;0.06MG/5ML;0.005MG/5ML;15MG/5ML;0.005MG/5ML;0.6MG/5ML;40MG/5ML;6MG/5ML;3.6MG/5ML;6MG/5ML;1MG/5ML;10MG/5ML;0.15MG/5ML	INJECTABLE;INTRAVENOUS	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021643

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/18/2004	ORIG-1	Approval		STANDARD	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21643ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021643s000_MVI_AdultTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/09/2017	SUPPL-19	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021625s023,021643s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021625Orig1s023,021643Orig1s019ltr.pdf
01/21/2015	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021625s018,021643s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021643Orig1s015,021625Orig1s018ltr.pdf
03/19/2013	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
11/24/2009	SUPPL-8	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Labels for NDA 021643

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/09/2017	SUPPL-19	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021625s023,021643s019lbl.pdf
01/21/2015	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021625s018,021643s015lbl.pdf

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