THE ORANGE BOOK ARCHIVES

1979 – Proposed Version

1980 – 1st Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12; Supplement 13

1981 – 2nd Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12

1982 – 3rd Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12

1983 – 4th Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12

1984 – 5th Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12

1985 – 6th Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12; Supplement 13; Supplement 14; Supplement 15; Supplement 16

1987 – 7th Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12

1988 – 8th Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12

1989 – 9th Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12

1990 – 10th Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12

1991 – 11th Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12

1992 – 12th Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12

1993 – 13th Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12

1994 – 14th Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12

1995 – 15th Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12

1996 – 16th Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12

1997 – 17th Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12

1998 – 18th Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12

1999 – 19th Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12

2000 – 20th Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12

2001 – 21st Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12

2002 – 22nd Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12

2003 – 23rd Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12

2004 – 24th Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12

2005 – 25th Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12

2006 – 26th Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12

2007 – 27th Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12

2008 – 28th Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12

2009 – 29th Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12

2010 – 30th Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12

2011 – 31st Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12

2012 – 32nd Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12

2013 – 33rd Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12

2014 – 34th Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12

2015 – 35th Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12

2016 – 36th Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12

2017 – 37th Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12

2018 – 38th Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12

2019 – 39th Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12

2020 – 40th Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12

2020 – Special BPCIA Transition Edition

List of Withdrawn Applications for Biological Products That Were Removed From FDA’s Orange Book on March 23, 2020

List of Approved NDAs for Biological Products That Were Deemed to be BLAs on March 23, 2020

2021 – 41st Edition

Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12