Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016097
Company: MERCK SHARP DOHME
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MINTEZOL THIABENDAZOLE 500MG/5ML SUSPENSION;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
04/21/1967 ORIG-1 Approval Type 3 - New Dosage Form 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
06/11/2003 SUPPL-26 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-25 Manufacturing (CMC)

Label is not available on this site.

06/29/2001 SUPPL-24 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16096s30ltr.pdf
06/03/1996 SUPPL-23 Labeling

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.

04/06/1987 SUPPL-18 Labeling

Label is not available on this site.

04/01/1985 SUPPL-17 Labeling

Label is not available on this site.

11/09/1983 SUPPL-15 Labeling

Label is not available on this site.

04/17/1978 SUPPL-13 Labeling

Label is not available on this site.

05/03/1977 SUPPL-12 Labeling

Label is not available on this site.

09/09/1976 SUPPL-11 Labeling

Label is not available on this site.

06/24/1976 SUPPL-10 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/30/1975 SUPPL-9 Labeling

Label is not available on this site.

02/21/1975 SUPPL-8 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-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16096slr033,16097slr026_mintezol_lbl.pdf

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