NDA 8845, held by Hospira. Succinylcholine Chloride.
As of Nov 13, 2026, NDA 8845 (Quelicin Preservative Free, Quelicin), held by Hospira, was first approved by FDA on May 1, 1953, with 48 approved supplements and 0 published complete response letters.
QUELICIN is indicated in adults and pediatric patients:
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 1, 1953 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Quelicin Preservative Free20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Succinylcholine Chloride | DiscontinuedReference drug |
| Quelicin Preservative Free50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Succinylcholine Chloride | DiscontinuedReference drug |
| Quelicin Preservative Free100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Succinylcholine Chloride | DiscontinuedReference drug |
| Quelicin20MG/ML · injectable;injection | Succinylcholine Chloride | RxReference drug |
| Dec 1, 2023 | Supplement 81Manufacturing | Approved | |
| Nov 1, 2022 | Supplement 80Labeling · Standard review | Approved | |
| Feb 17, 2022 | Supplement 79Labeling · Standard review | Approved | |
| Aug 11, 2021 | Supplement 76Labeling · Standard review | Approved | |
| Jul 26, 2018 | Supplement 73Labeling · Standard review | Approved | |
| Jul 30, 2014 | Supplement 70Manufacturing · Standard review | Approved | None posted |
| Mar 19, 2013 | Supplement 69Manufacturing · Standard review | Approved | None posted |
| Nov 22, 2010 | Supplement 65Labeling | Approved | |
| Dec 17, 2002 | Supplement 55Manufacturing · Standard review | Approved | None posted |
| Nov 17, 2000 | Supplement 54Manufacturing · Standard review | Approved | None posted |
| Jun 30, 2000 | Supplement 53Labeling · Standard review | Approved | None posted |
| Jan 29, 1999 | Supplement 52Labeling · Standard review | Approved | None posted |
| Jan 29, 1999 | Supplement 49Labeling · Standard review | Approved | None posted |
| May 26, 1998 | Supplement 50Manufacturing · Standard review | Approved | None posted |
| Oct 27, 1997 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Nov 28, 1994 | Supplement 47Labeling · Standard review | Approved | None posted |
| May 3, 1989 | Supplement 46Labeling | Approved | None posted |
| May 3, 1989 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| May 27, 1988 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Sep 1, 1987 | Supplement 42Labeling | Approved | None posted |
| Sep 1, 1987 | Supplement 41Labeling | Approved | None posted |
| Sep 1, 1987 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Mar 16, 1987 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Jun 27, 1984 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| May 5, 1982 | Supplement 34Labeling | Approved | None posted |
| Mar 16, 1982 | Supplement 28Labeling | Approved | None posted |
| Nov 10, 1981 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Oct 23, 1981 | Supplement 33Labeling | Approved | None posted |
| Aug 6, 1981 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| May 16, 1981 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Feb 10, 1981 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Dec 3, 1980 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Sep 3, 1980 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Sep 3, 1980 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Sep 3, 1980 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Dec 11, 1979 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Aug 22, 1978 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Apr 18, 1978 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Sep 6, 1977 | Supplement 19Labeling | Approved | None posted |
| Sep 6, 1977 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Jun 20, 1977 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Dec 14, 1976 | Supplement 17Labeling | Approved | None posted |
| Dec 14, 1976 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Dec 14, 1976 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Jul 20, 1976 | Supplement 15Labeling | Approved | None posted |
| Jun 22, 1976 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| May 6, 1976 | Supplement 13Labeling | Approved | None posted |
| May 6, 1976 | Supplement 12Labeling | Approved | None posted |
| May 1, 1953 | Original applicationNew formulation or manufacturer · Standard 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
