Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 010155
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MYTELASE AMBENONIUM CHLORIDE 10MG TABLET;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
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.

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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