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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016096
Company: MERCK SHARP DOHME

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MINTEZOL THIABENDAZOLE 500MG TABLET, CHEWABLE;ORAL 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
04/07/1967 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
06/11/2003 SUPPL-33 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16096slr033,16097slr026_mintezol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16096slr033,16097slr026ltr.pdf
10/24/2002 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.
03/27/2002 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.
06/29/2001 SUPPL-30 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16096s30ltr.pdf
08/07/1996 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.
12/26/1995 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.
06/16/1994 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.
07/01/1992 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.
12/30/1991 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.
06/03/1996 SUPPL-24 Labeling

Label is not available on this site.
11/19/1990 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.
04/04/1990 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.
10/18/1985 SUPPL-21 Labeling

Label is not available on this site.
01/23/1985 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.
08/09/1984 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.
04/06/1987 SUPPL-17 Labeling

Label is not available on this site.
04/01/1985 SUPPL-16 Labeling

Label is not available on this site.
11/07/1983 SUPPL-15 Labeling

Label is not available on this site.
11/07/1983 SUPPL-14 Labeling

Label is not available on this site.
06/04/1981 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.
04/17/1978 SUPPL-12 Labeling

Label is not available on this site.
05/03/1977 SUPPL-11 Labeling

Label is not available on this site.
06/24/1976 SUPPL-9 Manufacturing (CMC)-Formulation

Label is not available on this site.
04/15/1976 SUPPL-8 Labeling

Label is not available on this site.
02/25/1975 SUPPL-7 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
06/11/2003 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16096slr033,16097slr026_mintezol_lbl.pdf
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