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Back to Companies who have applied for FDA Drug Approval
FDA Drug Approval Applications Sponsored by ENDO PHARMS
Application Number
Drugs/Products
Application Type
Most Recent Label Available Flag
Current Patent Flag
Action Type
Chemical Type
Ther Potential
Orphan Code
005213
HYCODAN
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
007337
PERCODAN
PERCODAN-DEMI
New Drug Application
Approval
New combination
(S) Standard review drug
009165
DELATESTRYL
New Drug Application
Approval
New ester, new salt, or other noncovalent derivative
(P) Priority review drug
011707
OPANA
New Drug Application
Approval
New formulation
(S) Standard review drug
(V) Orphan drug
011738
NUMORPHAN
New Drug Application
Approval
New formulation
(S) Standard review drug
(V) Orphan drug
013428
VALPIN 50
New Drug Application
Approval
New formulation
(S) Standard review drug
016020
SYMMETREL
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
016023
SYMMETREL
New Drug Application
Approval
New formulation
(P) Priority review drug
017111
MOBAN
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
017118
SYMMETREL
New Drug Application
Approval
New indication
(P) Priority review drug
017938
MOBAN
New Drug Application
Approval
New formulation
(S) Standard review drug
018101
SYMMETREL
New Drug Application
Approval
New formulation
(S) Standard review drug
021006
FROVA
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
021463
FORTESTA
New Drug Application
Approval
New formulation
(S) Standard review drug
021610
OPANA ER
New Drug Application
Approval
New formulation
(S) Standard review drug
021611
OPANA
New Drug Application
Approval
New formulation
(S) Standard review drug
075923
OXYCODONE HYDROCHLORIDE
Abbreviated New Drug Application
Tentative Approval
201655
OPANA ER
New Drug Application
Approval
New manufacturer
(P) Priority review drug
Back to Companies who have applied for FDA Drug Approval