NDA 20793, held by Hikma. Caffeine Citrate.
As of Nov 13, 2026, NDA 20793 (Cafcit), held by Hikma, was first approved by FDA on Sep 21, 1999, with 8 approved supplements and 0 published complete response letters.
| Apr 12, 2000 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Sep 21, 1999 | Original applicationNew active ingredient · Priority review | Approved |
| CafcitEQ 30MG BASE/3ML (EQ 10MG BASE/ML) · solution;intravenous | Caffeine Citrate | RxReference drug |
| CafcitEQ 30MG BASE/3ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;oral | Caffeine Citrate | DiscontinuedReference drug |
| Mar 2, 2020 | Supplement 19Labeling · Standard review | Approved | |
| Dec 23, 2014 | Supplement 16Manufacturing · Priority review | Approved | None posted |
| Jun 11, 2010 | Supplement 9Labeling | Approved | |
| Mar 8, 2002 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Feb 8, 2002 | Supplement 4Labeling · Standard review | Approved | |
| Jan 18, 2002 | Supplement 3Labeling · Standard review | Approved | |
| Apr 14, 2000 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Apr 12, 2000 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Sep 21, 1999 | Original applicationNew active ingredient · Priority review | Approved |
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
