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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016097
Company: MERCK SHARP DOHME

Products on NDA 016097

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MINTEZOL	THIABENDAZOLE	500MG/5ML	SUSPENSION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 016097

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.

Labels for NDA 016097

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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