Application Number | Drugs/Products | Application Type | Most Recent Label Available Flag | Current Patent Flag | Action Type | Chemical Type | Ther Potential | Orphan Code |
005619 |
|
New Drug Application
| | |
Approval
|
|
|
|
005620 |
|
New Drug Application
| | |
Approval
|
|
|
|
006668 |
|
New Drug Application
| | |
Approval
|
|
|
|
007110 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(P) Priority review drug
|
|
007750 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
007898 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(P) Priority review drug
|
|
008228 |
|
New Drug Application
| | |
Approval
|
New ester, new salt, or other noncovalent derivative
|
(S) Standard review drug
|
|
008472 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
008506 |
|
New Drug Application
| | |
Approval
|
New ester, new salt, or other noncovalent derivative; New combination
|
(P) Priority review drug
|
|
009018 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
009193 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(P) Priority review drug
|
|
009509 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(P) Priority review drug
|
|
010520 |
|
New Drug Application
| | |
Approval
|
New ester, new salt, or other noncovalent derivative
|
(S) Standard review drug
|
|
010562 |
|
New Drug Application
| | |
Approval
|
New ester, new salt, or other noncovalent derivative
|
(S) Standard review drug
|
|
010585 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(S) Standard review drug
|
|
010656 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
011028 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
011583 |
|
New Drug Application
| | |
Approval
|
New combination
|
(S) Standard review drug
|
|
011635 |
|
New Drug Application
| | |
Approval
|
New combination
|
(S) Standard review drug
|
|
011664 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(P) Priority review drug
|
|
011835 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
011860 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(S) Standard review drug
|
|
011958 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
011977 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
011983 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
011984 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
012052 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
012071 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
012376 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
012383 |
|
New Drug Application
| | |
Approval
|
New combination
|
(S) Standard review drug
|
|
012649 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(S) Standard review drug
|
|
012731 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
013220 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
013334 |
|
New Drug Application
| | |
Approval
|
New combination
|
(S) Standard review drug
|
|
013400 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(P) Priority review drug
|
|
013401 |
|
New Drug Application
| | |
Approval
|
New ester, new salt, or other noncovalent derivative
|
(P) Priority review drug
|
|
013402 |
|
New Drug Application
| | |
Approval
|
New combination
|
(S) Standard review drug
|
|
013538 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
016016 |
|
New Drug Application
| | |
Approval
|
New combination
|
(S) Standard review drug
|
|
016675 |
|
New Drug Application
| | |
Approval
|
New ester, new salt, or other noncovalent derivative
|
(S) Standard review drug
|
|
017911 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(S) Standard review drug
|
|
018017 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(P) Priority review drug
|
|
018061 |
|
New Drug Application
| | |
Approval
|
New combination
|
(S) Standard review drug
|
|
018201 |
|
New Drug Application
| | |
Approval
|
New combination
|
(S) Standard review drug
|
|
018389 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
018445 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(P) Priority review drug
|
|
019384 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(P) Priority review drug
|
|
019510 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
019558 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(S) Standard review drug
|
|
019643 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(P) Priority review drug
|
|
019757 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
019766 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(S) Standard review drug
|
|
019778 |
|
New Drug Application
| | |
Approval
|
New combination
|
(S) Standard review drug
|
|
020180 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(P) Priority review drug
|
|
020408 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(P) Priority review drug
|
|
020506 |
|
New Drug Application
| | |
Approval
|
New ester, new salt, or other noncovalent derivative
|
(S) Standard review drug
|
|
020752 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
020788 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
020829 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(S) Standard review drug
|
|
020830 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
020864 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(S) Standard review drug
|
|
020865 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
021042 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(P) Priority review drug
|
|
021052 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(P) Priority review drug
|
|
021227 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(P) Priority review drug
|
|
021409 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
021549 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(P) Priority review drug
|
|
021575 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
021647 |
|
New Drug Application
| | |
Approval
|
New indication
|
(S) Standard review drug
|
|
021762 |
|
New Drug Application
| | |
Approval
|
New combination
|
(S) Standard review drug
|
|
021991 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(P) Priority review drug
|
(V) Orphan drug
|
050322 |
|
New Drug Application
| | |
Approval
|
|
|
|
050324 |
|
New Drug Application
| | |
Approval
|
|
|
|
050378 |
|
New Drug Application
| | |
Approval
|
|
|
|
050581 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
050587 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME); New combination
|
(P) Priority review drug
|
|
050630 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
062756 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
080778 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
101063 |
|
Biologic License Application
| | |
Approval
|
|
|
|