Application Number | Drugs/Products | Application Type | Most Recent Label Available Flag | Current Patent Flag | Action Type | Chemical Type | Ther Potential | Orphan Code |
004125 |
|
New Drug Application
| | |
Approval
|
|
|
|
005545 |
|
New Drug Application
| | |
Approval
|
|
|
|
005856 |
|
New Drug Application
| | |
Approval
|
|
|
|
005932 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
006044 |
|
New Drug Application
| | |
Approval
|
|
|
|
006800 |
|
New Drug Application
| | |
Approval
|
|
|
|
006905 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
007707 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(P) Priority review drug
|
|
008322 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(S) Standard review drug
|
|
010021 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
010599 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(S) Standard review drug
|
|
010796 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(S) Standard review drug
|
|
011971 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
012003 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(S) Standard review drug
|
|
012148 |
|
New Drug Application
| | |
Approval
|
New combination
|
(S) Standard review drug
|
|
012302 |
|
New Drug Application
| | |
Approval
|
New ester, new salt, or other noncovalent derivative
|
(P) Priority review drug
|
|
012418 |
|
New Drug Application
| | |
Approval
|
New ester, new salt, or other noncovalent derivative
|
(S) Standard review drug
|
|
012524 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(S) Standard review drug
|
|
018081 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(P) Priority review drug
|
|
018082 |
|
New Drug Application
| | |
Approval
|
New ester, new salt, or other noncovalent derivative; New formulation
|
(P) Priority review drug
|
|
018117 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
018279 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
018450 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
018651 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(P) Priority review drug
|
(V) Orphan drug
|
018723 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
018874 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
019204 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(S) Standard review drug
|
|
019304 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(S) Standard review drug
|
|
019680 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
019946 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(S) Standard review drug
|
|
020032 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(S) Standard review drug
|
(V) Orphan drug
|
020098 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(P) Priority review drug
|
|
020200 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
020381 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
020478 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(S) Standard review drug
|
|
020528 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(S) Standard review drug
|
|
020551 |
|
New Drug Application
| | |
Approval
|
New ester, new salt, or other noncovalent derivative
|
(S) Standard review drug
|
|
020591 |
|
New Drug Application
| | |
Approval
|
New combination
|
(S) Standard review drug
|
|
020593 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
020659 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(P) Priority review drug
|
|
020716 |
|
New Drug Application
| | |
Approval
|
New combination
|
(S) Standard review drug
|
|
020725 |
|
New Drug Application
| | |
Approval
|
Drug already marketed, but without an approved NDA
|
(P) Priority review drug
|
|
020738 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(S) Standard review drug
|
|
020819 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(S) Standard review drug
|
|
020945 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
021015 |
|
New Drug Application
| | |
Approval
|
New formulation
|
|
|
021168 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
021226 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME); New combination
|
(P) Priority review drug
|
|
021249 |
|
New Drug Application
| | |
Approval
|
New combination
|
(S) Standard review drug
|
|
021251 |
|
New Drug Application
| | |
Approval
|
New formulation; New combination
|
(P) Priority review drug
|
|
021268 |
|
New Drug Application
| | |
Approval
|
New combination
|
(S) Standard review drug
|
|
021402 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
021606 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
021656 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
021906 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(P) Priority review drug
|
|
022078 |
|
New Drug Application
| | |
Approval
|
New combination
|
(S) Standard review drug
|
|
022224 |
|
New Drug Application
| | |
Approval
|
New ester, new salt, or other noncovalent derivative
|
(S) Standard review drug
|
|
022309 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
022417 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
040117 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
050662 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(P) Priority review drug
|
|
050698 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
050739 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(S) Standard review drug
|
|
050749 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
050775 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
065003 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
065025 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
065027 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
071295 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
074638 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
075114 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
075729 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
087847 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
087848 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
087853 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
088058 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
089736 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|