Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 010679
Company: SANOFI AVENTIS US

Products on NDA 010679

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CANTIL	MEPENZOLATE BROMIDE	25MG	TABLET;ORAL	Discontinued	None	Yes	No
CANTIL	MEPENZOLATE BROMIDE	25MG/5ML	SOLUTION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 010679

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/14/1956	ORIG-1	Approval	Type 1 - New Molecular Entity	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
05/25/2004	SUPPL-29	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/10679slr029_cantil_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/10679slr029ltr.pdf
01/29/1999	SUPPL-27	Manufacturing (CMC)-Control		Label is not available on this site.
01/11/1989	SUPPL-26	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/15/1985	SUPPL-25	Manufacturing (CMC)-Packaging		Label is not available on this site.
11/09/1982	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
05/08/1991	SUPPL-23	Labeling		Label is not available on this site.
11/04/1980	SUPPL-21	Labeling		Label is not available on this site.
11/09/1982	SUPPL-19	Manufacturing (CMC)-Packaging		Label is not available on this site.
06/20/1980	SUPPL-17	Labeling		Label is not available on this site.

Labels for NDA 010679

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/25/2004	SUPPL-29	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/10679slr029_cantil_lbl.pdf