Prevents pregnancy in females of reproductive potential for up to 10 years. Sold as Cu-7, Tatum-T, Paragard T 380a, Miudella. Every FDA application for this active ingredient.
As of Nov 13, 2026, FDA lists 4 applications for Copper (sold as Cu-7, Tatum-T, Paragard T 380a and others), first approved Nov 15, 1984, with 5 new uses approved and 0 published complete response letters.
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Nov 15, 1984 | Paragard T 380aNDA 18680 · New dosage form | Coopersurgical | 54 | Marketed |
| Feb 24, 2025 | MiudellaNDA 218201 · New formulation or manufacturer | Sebela Womens Hlth | 1 | Marketed |
| — | Cu-7NDA 17408 | Gd Searle LLC | 0 | Discontinued |
| — | Tatum-TNDA 18205 | Gd Searle LLC | 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. Drugs@FDA
