NDA 7959, held by Pai Holdings Pharm. Edrophonium Chloride.
As of Nov 14, 2026, NDA 7959 (Tensilon, Tensilon Preservative Free), held by Pai Holdings Pharm, was first approved by FDA on May 3, 1951, with 7 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 3, 1951 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Tensilon10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Edrophonium Chloride | DiscontinuedReference drug |
| Tensilon Preservative Free10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Edrophonium Chloride | DiscontinuedReference drug |
| Feb 26, 2003 | Supplement 15Labeling · Standard review | Approved | |
| Apr 24, 2002 | Supplement 13Labeling · Standard review | Approved | |
| Oct 1, 1997 | Supplement 14Manufacturing · Priority review | Approved | None posted |
| Aug 9, 1993 | Supplement 12Manufacturing · Priority review | Approved | None posted |
| Jan 3, 1986 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Mar 7, 1985 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Apr 5, 1983 | Supplement 6Labeling | Approved | None posted |
| May 3, 1951 | Original applicationNew molecular entity · Priority review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
