Drugs@FDA: FDA-Approved Drugs
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| M.V.I. PEDIATRIC | ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E | 80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL;5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL;17MG/VIAL;0.2MG/VIAL;1MG/VIAL;1.4MG/VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/VIAL | FOR SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 04/06/1983 | ORIG-1 | Approval | Type 4 - New Combination | PRIORITY; Orphan |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/14/2019 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018920s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018920Orig1s038ltr.pdf | |
| 11/09/2017 | SUPPL-36 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018920s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018920Orig1s036ltr.pdf | |
| 06/27/2013 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/30/2001 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/09/2002 | SUPPL-24 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18920s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18920slr024ltr.pdf | |
| 06/05/2001 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/02/2000 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/21/2000 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/21/2000 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 06/05/2001 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/12/2000 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/13/1999 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/16/1998 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/25/1998 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 04/09/1996 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 01/19/1996 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/18/1995 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/26/1995 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/24/1993 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/22/1993 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 04/19/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 06/22/1989 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 12/08/1986 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/03/1986 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 05/15/1985 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 07/06/1984 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 07/06/1984 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/14/2019 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018920s038lbl.pdf | |
| 11/09/2017 | SUPPL-36 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018920s036lbl.pdf | |
| 07/09/2002 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18920s024lbl.pdf |