Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021643
Company: HOSPIRA
Company: HOSPIRA
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 |
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. |
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 |