Application Number | Drugs/Products | Application Type | Most Recent Label Available Flag | Current Patent Flag | Action Type | Chemical Type | Ther Potential | Orphan Code |
004589 |
|
New Drug Application
| | |
Approval
|
|
|
|
006170 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
014738 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
016080 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
016704 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
016730 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
016733 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
016734 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
016741 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
016772 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
016784 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
016822 |
|
New Drug Application
| | |
Approval
|
New combination
|
(P) Priority review drug
|
|
017038 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
017464 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
017510 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
017766 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
017995 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
018023 |
|
New Drug Application
| | |
Approval
|
|
|
|
018026 |
|
New Drug Application
| | |
Approval
|
|
|
|
018030 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
018046 |
|
New Drug Application
| | |
Approval
|
|
|
|
018047 |
|
New Drug Application
| | |
Approval
|
|
|
|
018156 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
018161 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
018184 |
|
New Drug Application
| | |
Approval
|
|
|
|
018186 |
|
New Drug Application
| | |
Approval
|
|
|
|
018229 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
018252 |
|
New Drug Application
| | |
Approval
|
|
|
|
018256 |
|
New Drug Application
| | |
Approval
|
|
|
|
018258 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
018268 |
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.075% |
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER |
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER |
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER |
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER |
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER |
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER |
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.30% IN PLASTIC CONTAINER |
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.075% |
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER |
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER |
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
018269 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
018270 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
018271 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
018273 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
018274 |
|
New Drug Application
| | |
Approval
|
|
|
|
018358 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
018376 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
018386 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
018460 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
018582 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
018674 |
|
New Drug Application
| | |
Approval
|
|
|
|
018676 |
|
New Drug Application
| | |
Approval
|
New formulation
|
(S) Standard review drug
|
|
018681 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
018721 |
|
New Drug Application
| | |
Approval
|
|
|
|
018722 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
018725 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
018744 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
018807 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
018899 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
018900 |
|
New Drug Application
| | |
Approval
|
|
|
|
018967 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
019006 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
019018 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
019024 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
019025 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
019042 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
019077 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
019083 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
019099 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
019121 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
019134 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
019135 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
019212 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
019530 |
|
New Drug Application
| | |
Approval
|
New molecular entity (NME); New combination
|
(P) Priority review drug
|
(V) Orphan drug
|
019531 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
019626 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
019630 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
019631 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
019632 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
019633 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
019634 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
019635 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
019696 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
019699 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
019708 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
019711 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
019718 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
019802 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
019826 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
019830 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
019843 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
019844 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
019864 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
019867 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
019870 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
019873 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
019952 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
019953 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
020000 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
020002 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
020004 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
020006 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
050779 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
050780 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
050792 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
050796 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
050821 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
050823 |
|
New Drug Application
| | |
Approval
|
New manufacturer
|
(S) Standard review drug
|
|
062814 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
065214 |
|
New Drug Application
| | |
Approval
|
|
|
|
065430 |
|
New Drug Application
| | |
Approval
|
|
|
|
076414 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
085734 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
085870 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
091112 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|
091387 |
|
Abbreviated New Drug Application
| | |
Approval
|
|
|
|