FDA Orange Book
Approved drug products with therapeutic equivalence evaluations. Switch to the table view for the full archive in a spreadsheet-style grid.
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Approved drug products with therapeutic equivalence evaluations. Switch to the table view for the full archive in a spreadsheet-style grid.
FDA Orange Book, published monthly. Last pulled Sep 1, 2026. Most recent approval Aug 13, 2026.
Prescription, over-the-counter and discontinued listings
| 24,754 | 50.9% | |
| 23,123 | 47.5% | |
| 787 | 1.6% |
Listings approved under an NDA against those under an ANDA
| 37,795 | 77.7% | |
| 10,869 | 22.3% |