Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 008809
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| M.V.I.-12 ADULT | ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E | 10MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;20 IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.36MG/ML;0.3MG/ML;330 UNITS/ML;1 IU/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| M.V.I.-12 ADULT | ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E | 20MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;20 IU/ML;0.6MG/ML;4MG/ML;0.4MG/ML;0.36MG/ML;0.6MG/ML;330 UNITS/ML;1 IU/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| M.V.I.-12 ADULT | ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E | 20MG/ML;0.006MG/ML;0.05MCG/ML;1.5MG/ML;0.0005MG/ML;0.06MG/ML;4MG/ML;0.6MG/ML;0.36MG/ML;0.6MG/ML;0.1MG/ML;1MG/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 02/20/1953 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/09/2017 | SUPPL-73 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008809s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/008809Orig1s073ltr.pdf | |
| 09/18/2015 | SUPPL-72 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/19/2013 | SUPPL-69 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/03/2015 | SUPPL-67 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/26/2013 | SUPPL-66 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/008809s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/008809Orig1s066ltr.pdf | |
| 06/14/2012 | SUPPL-65 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/008809s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/008809s065ltr.pdf | |
| 11/24/2009 | SUPPL-60 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/09/2004 | SUPPL-54 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/08809s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/08809s054ltr.pdf | |
| 04/22/2004 | SUPPL-52 | Manufacturing (CMC)-Formulation |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/08809scf052_mvi-12_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/08809scf052ltr.pdf | |
| 11/14/2002 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/04/2002 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/04/2002 | SUPPL-46 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/8809s046ltr.pdf |
| 04/17/2001 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/17/2001 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/10/2001 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/02/1999 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/25/1999 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/18/1998 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/12/1998 | SUPPL-39 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/31/1997 | SUPPL-38 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/30/1998 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/22/1997 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/13/1997 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/19/1996 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/27/1995 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/26/1995 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/24/1993 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/03/1993 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/02/1993 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/19/1991 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 12/07/1990 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/22/1989 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 08/08/1985 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 04/24/1985 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/25/1985 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/20/1984 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 06/23/1980 | SUPPL-5 | Labeling |
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-73 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008809s073lbl.pdf | |
| 11/09/2017 | SUPPL-73 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008809s073lbl.pdf | |
| 03/26/2013 | SUPPL-66 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/008809s066lbl.pdf | |
| 06/14/2012 | SUPPL-65 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/008809s065lbl.pdf | |
| 09/09/2004 | SUPPL-54 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/08809s054lbl.pdf | |
| 04/22/2004 | SUPPL-52 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/08809scf052_mvi-12_lbl.pdf |