Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021625
Company: HOSPIRA
Company: HOSPIRA
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 |
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.cfm |
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. |
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06/11/2015 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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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. |
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03/19/2013 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/24/2009 | SUPPL-9 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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 |