Application Number | Drugs/Products | Application Type | Most Recent Label Available Flag | Current Patent Flag | Action Type | Chemical Type | Ther Potential | Orphan Code |
002245 |
|
New Drug Application
| | |
Approval
|
|
|
|
003402 |
|
New Drug Application
| | |
Approval
|
|
|
|
006441 |
|
New Drug Application
| | |
Approval
|
|
|
|
006514 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
007984 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(S) Standard review drug
|
|
008041 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(P) Priority review drug
|
|
008762 |
|
New Drug Application
| | |
Approval
|
New ester, new salt, or other noncovalent derivative
|
(S) Standard review drug
|
|
008855 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(P) Priority review drug
|
|
009078 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(S) Standard review drug
|
|
009268 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(S) Standard review drug
|
|
010151 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
010596 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(P) Priority review drug
|
|
010895 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(P) Priority review drug
|
|
010962 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
011909 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(S) Standard review drug
|
|
011964 |
|
New Drug Application
| | |
Approval
|
New ester, new salt, or other noncovalent derivative
|
(S) Standard review drug
|
|
012184 |
|
New Drug Application
| | |
Approval
|
New ester, new salt, or other noncovalent derivative
|
(S) Standard review drug
|
|
012380 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(P) Priority review drug
|
|
012485 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
014696 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(S) Standard review drug
|
|
016680 |
|
New Drug Application
| | |
Approval
|
New ester, new salt, or other noncovalent derivative; New combination
|
(S) Standard review drug
|
|
016723 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
016749 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
016766 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
016768 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(S) Standard review drug
|
|
016852 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
016854 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
016998 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
017244 |
|
New Drug Application
| | |
Approval
|
New ester, new salt, or other noncovalent derivative
|
(S) Standard review drug
|
|
017346 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
017415 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(S) Standard review drug
|
|
017528 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
018006 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(S) Standard review drug
|
|
018089 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
018144 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
018588 |
|
New Drug Application
| | |
Approval
|
|
|
|
018806 |
|
New Drug Application
| | |
Approval
|
|
|
|
019014 |
|
New Drug Application
| | |
Approval
|
New combination
|
(S) Standard review drug
|
|
020417 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
020450 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(S) Standard review drug
|
|
021129 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
021216 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
021276 |
|
New Drug Application
| | |
Approval
|
New indication
|
(S) Standard review drug
|
|
021397 |
|
New Drug Application
| | |
Approval
|
New indication
|
(S) Standard review drug
|
|
021423 |
|
New Drug Application
| | |
Approval
|
New indication
|
(S) Standard review drug
|
|
021424 |
|
New Drug Application
| | |
Approval
|
New indication
|
(S) Standard review drug
|
|
050152 |
|
New Drug Application
| | |
Approval
|
|
|
|
050153 |
|
New Drug Application
| | |
Approval
|
|
|
|
050183 |
|
New Drug Application
| | |
Approval
|
|
|
|
050203 |
|
New Drug Application
| | |
Approval
|
|
|
|
050294 |
|
New Drug Application
| | |
Approval
|
|
|
|
050355 |
|
New Drug Application
| | |
Approval
|
|
|
|
060522 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
062001 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
062002 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
062003 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
062029 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
062030 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
062032 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
062041 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
062107 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
062127 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
062231 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
062301 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
062546 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
062618 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
062648 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
070331 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
070332 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
070333 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
070863 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
070871 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
070872 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
071508 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
071621 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
071739 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
071897 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
071898 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
071899 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
071900 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
080258 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
080364 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
080770 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
083625 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
083626 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
084156 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
084241 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
084243 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
084244 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
084349 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
084423 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
084598 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
084744 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
084762 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
084955 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
085079 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
085163 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
085164 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
085540 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
085804 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
085889 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
085994 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
085997 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
086047 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
086468 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
086885 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
086886 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
086887 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
086888 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
087131 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
087502 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
087948 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
089914 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|