橙皮书历史档案

美国橙皮书的历史文件下载1980-2021 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;