Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018439
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MVC PLUS | 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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/13/1982 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018439_01.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/10/1999 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/16/1998 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/26/1998 | SUPPL-18 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 09/26/1997 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/10/1996 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/24/1996 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/27/1996 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 10/14/1994 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/01/1993 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/05/1989 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/29/1986 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/14/1985 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/17/1983 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |