Sold as Cylert. Every FDA application for this active ingredient: 2 branded and 8 generic.
As of Nov 13, 2026, FDA lists 10 applications for Pemoline (sold as Cylert), first approved Jan 27, 1975, with 0 new uses approved and 0 published complete response letters.
| Study | Phase | Status | Posted |
|---|---|---|---|
| Effect Clomiphene vs Clomiphene Along With Pioglitazone on Ovarian Stimulation RateInfertility Treatment, Pregnancy Rates · PAEC General Hospital, Islamabad | Phase 4 | Recruiting | Mar 10, 2026 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Jan 27, 1975 | CylertNDA 16832 · New molecular entity | Abbott | 17 | Discontinued |
| Jan 30, 1976 | CylertNDA 17703 · New dosage form | Abbott | 12 | Discontinued |
| Jan 29, 1999 | PemolineANDA 75030 | Teva Pharms | 10 | Discontinued |
| Jun 30, 1999 | PemolineANDA 75286 | Fosun Pharma | 4 | Discontinued |
| Feb 18, 2000 | PemolineANDA 75555 | Teva Pharms | 6 | Discontinued |
| Feb 28, 2000 | PemolineANDA 75595 | Actavis Elizabeth | 0 | Discontinued |
| Apr 19, 2000 | PemolineANDA 75328 | Vintage Pharms | 0 | Discontinued |
| Jul 26, 2000 | PemolineANDA 75678 | Actavis Elizabeth | 0 | Discontinued |
| Sep 18, 2000 | PemolineANDA 75287 | Watson Labs | 3 | Discontinued |
| Mar 30, 2001 | PemolineANDA 75726 | Mallinckrodt | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Abbott
Mallinckrodt