Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 007959
Company: TELIGENT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TENSILON EDROPHONIUM CHLORIDE 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
TENSILON PRESERVATIVE FREE EDROPHONIUM CHLORIDE 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
05/03/1951 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/26/2003 SUPPL-15 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/7959s013s015.pdf
10/01/1997 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

04/24/2002 SUPPL-13 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/7959s013s015.pdf
08/09/1993 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/03/1986 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/07/1985 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/05/1983 SUPPL-6 Labeling

Label is not available on this site.

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