Application Number | Drugs/Products | Application Type | Most Recent Label Available Flag | Current Patent Flag | Action Type | Chemical Type | Ther Potential | Orphan Code |
009321 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
010040 |
|
New Drug Application
| | |
Approval
|
New ester, new salt, or other noncovalent derivative; New combination
|
(S) Standard review drug
|
|
010927 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
010929 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
011245 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
011324 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
011620 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
012967 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(P) Priority review drug
|
|
012968 |
|
New Drug Application
| | |
Approval
|
New ester, new salt, or other noncovalent derivative
|
(P) Priority review drug
|
|
013993 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
015419 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
016089 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
016090 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
016224 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(P) Priority review drug
|
|
016923 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
017045 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
017047 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(P) Priority review drug
|
|
017269 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
017339 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
017680 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
017697 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(P) Priority review drug
|
|
017833 |
|
New Drug Application
| | |
Approval
|
New ester, new salt, or other noncovalent derivative
|
(S) Standard review drug
|
|
017902 |
|
New Drug Application
| | |
Approval
|
New ester, new salt, or other noncovalent derivative
|
(S) Standard review drug
|
|
017903 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
018076 |
|
New Drug Application
| | |
Approval
|
New ester, new salt, or other noncovalent derivative
|
(S) Standard review drug
|
|
018077 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
018107 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
018548 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
018735 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(S) Standard review drug
|
|
018963 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(S) Standard review drug
|
|
019414 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(S) Standard review drug
|
|
019928 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(P) Priority review drug
|
|
020131 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(S) Standard review drug
|
|
020327 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
020686 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
020773 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
021357 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(S) Standard review drug
|
|
021358 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
021489 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
089347 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
203684 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME)
|
(S) Standard review drug
|
|
208036 |
|
New Drug Application
| | |
Approval
|
Drug already marketed, but without an approved NDA
|
(S) Standard review drug
|
|
208143 |
|
New Drug Application
| | |
Approval
|
Drug already marketed, but without an approved NDA
|
(S) Standard review drug
|
|
208844 |
|
New Drug Application
| | |
Approval
|
Drug already marketed, but without an approved NDA
|
|
|