Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 017481
Company: JANSSEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VERMOX MEBENDAZOLE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, CHEWABLE;ORAL Discontinued None Yes No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
06/28/1974 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/13/2017 SUPPL-47 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017481s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017481Orig1s047ltr.pdf
10/20/1998 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

07/27/1998 SUPPL-44 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/20/1998 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

03/20/1998 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

09/27/1995 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

06/16/1994 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

02/13/1998 SUPPL-38 Labeling

Label is not available on this site.

12/23/1993 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

01/28/1993 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

01/28/1993 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

09/28/1989 SUPPL-34 Labeling

Label is not available on this site.

01/26/1986 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

08/09/1984 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

08/31/1984 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

05/14/1984 SUPPL-28 Labeling

Label is not available on this site.

03/16/1983 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

03/16/1983 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

07/11/1983 SUPPL-25 Labeling

Label is not available on this site.

06/04/1981 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

12/29/1980 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

04/03/1980 SUPPL-20 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/01/1980 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/01/1980 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

03/08/1979 SUPPL-16 Labeling

Label is not available on this site.

03/08/1979 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

09/13/1979 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

02/15/1979 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/27/1978 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/24/1978 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/24/1977 SUPPL-9 Labeling

Label is not available on this site.

07/29/1977 SUPPL-8 Labeling

Label is not available on this site.

03/04/1977 SUPPL-7 Labeling

Label is not available on this site.

03/18/1976 SUPPL-6 Labeling

Label is not available on this site.

10/30/1975 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

10/30/1975 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

03/18/1976 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/13/2017 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017481s047lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English