Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018439
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.

02/26/1998 SUPPL-18 Manufacturing (CMC)-Formulation

Label is not available on this site.

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.

12/24/1996 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

02/27/1996 SUPPL-14 Labeling

Label is not available on this site.

10/14/1994 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

11/01/1993 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

12/05/1989 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/29/1986 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/14/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/17/1983 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

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