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Back to Companies who have applied for FDA Drug Approval
FDA Drug Approval Applications Sponsored by SEBELA IRELAND LTD
Application Number
Drugs/Products
Application Type
Most Recent Label Available Flag
Current Patent Flag
Action Type
Chemical Type
Ther Potential
Orphan Code
016084
ZYLOPRIM
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
016324
IMURAN
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
017391
IMURAN
New Drug Application
Approval
New formulation
(P) Priority review drug
017744
MOTOFEN
MOTOFEN HALF-STRENGTH
New Drug Application
Approval
New molecular entity (NME); New combination
(S) Standard review drug
018689
RIDAURA
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
019425
TRANDATE
New Drug Application
Approval
New manufacturer
(S) Standard review drug
021107
LOTRONEX
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
021299
PEXEVA
New Drug Application
Approval
New ester, new salt, or other noncovalent derivative
(S) Standard review drug
040396
MICORT-HC
Abbreviated New Drug Application
Approval
040398
MICORT-HC
Abbreviated New Drug Application
Approval
050719
HELIDAC
New Drug Application
Approval
New combination
(S) Standard review drug
083778
PRAMOSONE
Abbreviated New Drug Application
Approval
085368
PRAMOSONE
Abbreviated New Drug Application
Approval
085979
PRAMOSONE
Abbreviated New Drug Application
Approval
085980
PRAMOSONE
Abbreviated New Drug Application
Approval
204516
BRISDELLE
New Drug Application
Approval
New formulation
(S) Standard review drug
Back to Companies who have applied for FDA Drug Approval