Generic approvals since 1984
Drugs@FDA records 19,597 approved original abbreviated new drug applications. FDA approved 648 in 2025 and 579 so far in 2026.
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Original ANDA approvals per year
Drugs@FDAShow as table
| Year | Approvals |
|---|---|
| 1984 | 207 |
| 1985 | 291 |
| 1986 | 363 |
| 1987 | 389 |
| 1988 | 359 |
| 1989 | 147 |
| 1990 | 59 |
| 1991 | 165 |
| 1992 | 152 |
| 1993 | 153 |
| 1994 | 169 |
| 1995 | 182 |
| 1996 | 205 |
| 1997 | 255 |
| 1998 | 225 |
| 1999 | 185 |
| 2000 | 243 |
| 2001 | 218 |
| 2002 | 316 |
| 2003 | 256 |
| 2004 | 366 |
| 2005 | 332 |
| 2006 | 350 |
| 2007 | 470 |
| 2008 | 458 |
| 2009 | 457 |
| 2010 | 416 |
| 2011 | 457 |
| 2012 | 503 |
| 2013 | 406 |
| 2014 | 418 |
| 2015 | 561 |
| 2016 | 610 |
| 2017 | 833 |
| 2018 | 804 |
| 2019 | 819 |
| 2020 | 743 |
| 2021 | 624 |
| 2022 | 733 |
| 2023 | 754 |
| 2024 | 712 |
| 2025 | 648 |
| 2026 | 579 |
Counts use each application's original approval date. Applications approved before 1984 under earlier pathways also appear in Drugs@FDA. An approved application holder is not necessarily the company that manufactures the product.
Latest generic approvals
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Source: Drugs@FDA via openFDA. Sponsor names are omitted; follow the application link for FDA's record · data as of 2026-10-28. Figures can change and may contain errors in the source data. Check the original source before relying on them.