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Drug Approval Reports by Month Select a Report:

Reports include only BLAs/NDAs/ANDAs or supplements to those applications approved by the Center for Drug Evaluation and Research (CDER) and tentative NDA/ANDA approvals in CDER. The reports do not include applications or supplements approved by the All Approvals and Tentative Approvals by Month

Approvals of New Drug Applications (NDAs), Biologics License Applications (BLAs), and Abbreviated New Drug Applications (ANDAs), and supplements to those applications; and tentative approvals of ANDAs and NDAs. Reports include only BLAs/NDAs/ANDAs or supplements to those applications approved by the Center for Drug Evaluation and Research (CDER) and tentative NDA/ANDA approvals in CDER. The reports do not include applications or supplements approved by the Center for Biologics Evaluation and Research (CBER) Original NDA and Original BLA Approvals by Month

NDAs and BLAs approved for the first time during the selected month Original ANDA Approvals by Month

Original ANDA approvals (applications for generic drugs) Supplemental Approvals to NDAs and BLAs by Month

Supplemental approvals to NDAs and BLAs Tentative ANDA Approvals by Month

Tentatively approved applications for generic drugs Select a month and year Month: Select January February March April May June July August September October November December Year: Select 1900 1901 1902 1903 1904 1905 1906 1907 1908 1909 1910 1911 1912 1913 1914 1915 1916 1917 1918 1919 1920 1921 1922 1923 1924 1925 1926 1927 1928 1929 1930 1931 1932 1933 1934 1935 1936 1937 1938 1939 1940 1941 1942 1943 1944 1945 1946 1947 1948 1949 1950 1951 1952 1953 1954 1955 1956 1957 1958 1959 1960 1961 1962 1963 1964 1965 1966 1967 1968 1969 1970 1971 1972 1973 1974 1975 1976 1977 1978 1979 1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 Search Clear

* Drugs@FDA includes information about drugs, including biological products, approved for human use in the United States (see FAQ ), but does not include information about FDA-approved products regulated by the Center for Biologics Evaluation and Research (for example, vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products). For prescription brand-name drugs, Drugs@FDA typically includes the most recent labeling approved by the FDA (for example, Prescribing Information and FDA-approved patient labeling when available), regulatory information, and FDA staff reviews that evaluate the safety and effectiveness of the drug.