²é¿´: 1365  |  »Ø¸´: 2

organiccooker

½ð³æ (ÕýʽдÊÖ)

[½»Á÷] ¿ìÀ´¿´FDA¶Ô»¯Ò©·ÖÀà´úÂëµÄÒâÒå£¬ÌØ±ðÊÇOrphan drug ÊÇʲôÒâÒ壬ǧÍò±ðÍûÎÄÉúÒåŶ£¡ ÒÑÓÐ2È˲ÎÓë

What do the Chemical Type and Review Classification codes stand for?

NDA Chemical Types Number Meaning
1 New molecular entity (NME)
2 New active ingredient
3 New dosage form
4 New combination
5 New formulation or new manufacturer
6 New indication
7 Drug already marketed without an approved NDA
8 OTC (over-the-counter) switch
10 New indication submitted as distinct NDA - not consolidated



Review Classifications Letter Meaning
P Priority review drug: A drug that appears to represent an advance over available therapy
S Standard review drug: A drug that appears to have therapeutic qualities similar to those of an already marketed drug
O Orphan drug - a product that treats a rare disease affecting fewer than 200,000 Americans

¸öÈ˸оõÐÅÏ¢Á¿ËäС£¬È´ºÜÓÐÒâÒ壡
¸øµã¹ÄÀøÅ¶
»Ø¸´´ËÂ¥
ÒÑÔÄ   »Ø¸´´ËÂ¥   ¹Ø×¢TA ¸øTA·¢ÏûÏ¢ ËÍTAºì»¨ TAµÄ»ØÌû

lbdtian

ÖÁ×ðľ³æ (ÖøÃûдÊÖ)

¸Ðл¥Ö÷
2Â¥2013-08-16 10:57:30
ÒÑÔÄ   »Ø¸´´ËÂ¥   ¹Ø×¢TA ¸øTA·¢ÏûÏ¢ ËÍTAºì»¨ TAµÄ»ØÌû

3Â¥2018-10-26 10:46:54
ÒÑÔÄ   »Ø¸´´ËÂ¥   ¹Ø×¢TA ¸øTA·¢ÏûÏ¢ ËÍTAºì»¨ TAµÄ»ØÌû
Ïà¹Ø°æ¿éÌø×ª ÎÒÒª¶©ÔÄÂ¥Ö÷ organiccooker µÄÖ÷Ìâ¸üÐÂ
×î¾ßÈËÆøÈÈÌûÍÆ¼ö [²é¿´È«²¿] ×÷Õß »Ø/¿´ ×îºó·¢±í
[¿¼ÑÐ] 291 Çóµ÷¼Á +4 »¯¹¤2026½ì±ÏÒµÉ 2026-03-21 5/250 2026-03-23 16:46 by »¯¹¤2026½ì±ÏÒµÉ
[¿¼ÑÐ] Ò»Ö¾Ô¸ÉϺ£½»´óÉúÎïÓëҽҩר˶324·Ö£¬Çóµ÷¼Á +4 jiajunX 2026-03-22 4/200 2026-03-23 14:21 by xiaotangjing
[¿¼ÑÐ] 336Çóµ÷¼Á +3 ÊÕµ½VS 2026-03-20 3/150 2026-03-23 13:23 by Iveryant
[¿¼ÑÐ] ÇóÀÏʦÊÕÎÒ +3 zzh16938784 2026-03-23 3/150 2026-03-23 12:56 by ztnimte
[¿¼ÑÐ] 336»¯¹¤µ÷¼Á +3 Íõ´ó̹1 2026-03-23 4/200 2026-03-23 11:07 by laoshidan
[¿¼ÑÐ] 307Çóµ÷¼Á +11 ÀäóÏ123 2026-03-17 11/550 2026-03-22 20:16 by edmund7
[¿¼ÑÐ] Çóµ÷¼ÁÒ»Ö¾Ô¸º£´ó£¬0703»¯Ñ§Ñ§Ë¶304·Ö£¬Óдó´´ÏîÄ¿£¬Ëļ¶Òѹý +6 ÐÒÔËÁ¨Á¨ 2026-03-22 10/500 2026-03-22 20:10 by edmund7
[¿¼ÑÐ] 289²ÄÁÏÓ뻯¹¤£¨085600£©BÇøÇóµ÷¼Á +3 ÕâôÃû×ÖÕ¦Ñù 2026-03-22 4/200 2026-03-22 17:56 by ÔÆÃñ´óÀîÀÏʦ
[¿¼ÑÐ] ÉúÎïѧ071000 329·ÖÇóµ÷¼Á +5 ÎÒ°®ÉúÎïÉúÎﰮΠ2026-03-17 5/250 2026-03-22 16:42 by tcx007
[¿¼ÑÐ] 354Çóµ÷¼Á +7 Tyoumou 2026-03-18 10/500 2026-03-22 11:11 by ÈËÀ´Ê¢
[¿¼ÑÐ] ²ÄÁÏѧ˶301·ÖÇóµ÷¼Á +7 Liyouyumairs 2026-03-21 7/350 2026-03-21 22:31 by peike
[¿¼ÑÐ] ³õʼ318·ÖÇóµ÷¼Á£¨Óй¤×÷¾­Ñ飩 +3 1911236844 2026-03-17 3/150 2026-03-21 02:33 by JourneyLucky
[¿¼ÑÐ] Ò»Ö¾Ô¸ Î÷±±´óѧ £¬070300»¯Ñ§Ñ§Ë¶£¬×Ü·Ö287£¬Ë«·ÇÒ»±¾£¬Çóµ÷¼Á¡£ +3 ³¿»èÏßÓëÐǺ£ 2026-03-18 3/150 2026-03-21 00:46 by JourneyLucky
[¿¼ÑÐ] 321Çóµ÷¼Á +9 ºÎÈó²É123 2026-03-18 11/550 2026-03-20 23:19 by JourneyLucky
[¿¼ÑÐ] 330Çóµ÷¼Á +4 С²Ä»¯±¾¿Æ 2026-03-18 4/200 2026-03-20 23:13 by JourneyLucky
[¿¼ÑÐ] 304Çóµ÷¼Á +7 ˾¿Õ. 2026-03-18 7/350 2026-03-20 23:08 by JourneyLucky
[¿¼ÑÐ] Çóµ÷¼Á£¬Ò»Ö¾Ô¸:ÄϾ©º½¿Õº½Ìì´óѧ´óѧ £¬080500²ÄÁÏ¿ÆÑ§Ó빤³Ìѧ˶£¬×Ü·Ö289·Ö +4 @taotao 2026-03-19 4/200 2026-03-20 22:14 by JourneyLucky
[¿¼ÑÐ] ²ÄÁÏѧÇóµ÷¼Á +4 Stella_Yao 2026-03-20 4/200 2026-03-20 20:28 by ms629
[¿¼ÑÐ] Çóµ÷¼Á +3 @taotao 2026-03-20 3/150 2026-03-20 19:35 by JourneyLucky
[¿¼ÑÐ] 085600²ÄÁÏÓ뻯¹¤µ÷¼Á 324·Ö +10 llllkkkhh 2026-03-18 12/600 2026-03-19 14:33 by llllkkkhh
ÐÅÏ¢Ìáʾ
ÇëÌî´¦ÀíÒâ¼û