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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 010155
Company: SANOFI AVENTIS US

Products on NDA 010155

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MYTELASE	AMBENONIUM CHLORIDE	10MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 010155

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/01/1956	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
11/26/2014	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/010155s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/010155Orig1s024ltr.pdf
11/14/2011	SUPPL-23	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/010155s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/010155s022s023ltr.pdf
11/14/2011	SUPPL-22	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/010155s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/010155s022s023ltr.pdf
02/26/2003	SUPPL-21	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/10155slr021ltr.pdf
03/27/2002	SUPPL-20	Manufacturing (CMC)-Control		Label is not available on this site.
12/02/1991	SUPPL-19	Manufacturing (CMC)-Control		Label is not available on this site.
12/02/1991	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
03/09/1990	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
01/03/1986	SUPPL-15	Labeling		Label is not available on this site.
04/01/1982	SUPPL-13	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/20/1981	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
02/18/1981	SUPPL-11	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/02/1980	SUPPL-10	Labeling		Label is not available on this site.
02/06/1980	SUPPL-9	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/20/1977	SUPPL-8	Labeling		Label is not available on this site.
12/20/1977	SUPPL-7	Labeling		Label is not available on this site.

Labels for NDA 010155

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/26/2014	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/010155s024lbl.pdf
11/14/2011	SUPPL-23	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/010155s023lbl.pdf
11/14/2011	SUPPL-22	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/010155s022lbl.pdf

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