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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021625
Company: HOSPIRA

Products on NDA 021625

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021625

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/30/2004	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21625_MVI_Adult_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21625ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21625s000_MVI_AdultTOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/16/2020	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021625s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021625Orig1s024ltr.pdf
11/09/2017	SUPPL-23	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
06/24/2015	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
06/11/2015	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
01/21/2015	SUPPL-18	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
07/01/2014	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
03/19/2013	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
11/24/2009	SUPPL-9	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Labels for NDA 021625

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/16/2020	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021625s024lbl.pdf
11/09/2017	SUPPL-23	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021625s023,021643s019lbl.pdf
01/21/2015	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021625s018,021643s015lbl.pdf
01/30/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21625_MVI_Adult_lbl.pdf

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