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Back to Companies who have applied for FDA Drug Approval
FDA Drug Approval Applications Sponsored by UCB INC
Application Number
Drugs/Products
Application Type
Most Recent Label Available Flag
Current Patent Flag
Action Type
Chemical Type
Ther Potential
Orphan Code
010093
BIPHETAMINE 12.5
BIPHETAMINE 20
BIPHETAMINE 7.5
New Drug Application
Approval
New ester, new salt, or other noncovalent derivative
(S) Standard review drug
011613
IONAMIN
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
013413
DEXACORT
New Drug Application
Approval
New formulation
(S) Standard review drug
014242
DEXACORT
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017386
ZAROXOLYN
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
018050
CORSYM
New Drug Application
Approval
New manufacturer
(S) Standard review drug
019111
TUSSIONEX PENNKINETIC
New Drug Application
Approval
New combination
(S) Standard review drug
019188
GASTROCROM
New Drug Application
Approval
New formulation
(P) Priority review drug
(V) Orphan drug
019401
PSEUDO-12
New Drug Application
Approval
New ester, new salt, or other noncovalent derivative; New formulation
(S) Standard review drug
019532
MYKROX
New Drug Application
Approval
New formulation
(S) Standard review drug
020312
UNIVASC
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
020729
UNIRETIC
New Drug Application
Approval
New combination
(S) Standard review drug
021035
KEPPRA
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
021259
METADATE CD
New Drug Application
Approval
New formulation
(S) Standard review drug
021369
CODEPREX
New Drug Application
Approval
New formulation
(S) Standard review drug
021505
KEPPRA
New Drug Application
Approval
New formulation
(S) Standard review drug
021589
KEMSTRO
New Drug Application
Approval
New formulation
(S) Standard review drug
021712
FLUXID
New Drug Application
Approval
New formulation
(S) Standard review drug
021726
NIRAVAM
New Drug Application
Approval
New formulation
(S) Standard review drug
021829
NEUPRO
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
021872
KEPPRA
New Drug Application
Approval
New formulation
(S) Standard review drug
022064
XYZAL
New Drug Application
Approval
New manufacturer
(P) Priority review drug
022157
XYZAL
New Drug Application
Approval
New formulation
(S) Standard review drug
022253
VIMPAT
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
022254
VIMPAT
New Drug Application
Approval
New formulation
(S) Standard review drug
022255
VIMPAT
New Drug Application
Approval
New formulation
(S) Standard review drug
022285
KEPPRA XR
New Drug Application
Approval
New formulation
(S) Standard review drug
040100
LORTAB
Abbreviated New Drug Application
Approval
040134
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Abbreviated New Drug Application
Approval
040210
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Abbreviated New Drug Application
Approval
040306
METADATE ER
Abbreviated New Drug Application
Approval
073120
ALBUTEROL SULFATE
Abbreviated New Drug Application
Approval
073121
ALBUTEROL SULFATE
Abbreviated New Drug Application
Approval
076699
PARCOPA
Abbreviated New Drug Application
Approval
085171
GLUTETHIMIDE
Abbreviated New Drug Application
Approval
085544
DIETHYLPROPION HYDROCHLORIDE
Abbreviated New Drug Application
Approval
085799
METHYLPHENIDATE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
085864
AMITRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
085935
AMITRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
085936
AMITRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
086335
AMITRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
086336
AMITRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
086337
AMITRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
086428
METHYLPHENIDATE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
086429
METHYLPHENIDATE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
087722
LORTAB
Abbreviated New Drug Application
Approval
087757
CO-GESIC
Abbreviated New Drug Application
Approval
089601
METADATE ER
Abbreviated New Drug Application
Approval
125160
CIMZIA
Biologic License Application
Approval
205836
BRIVIACT
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
205837
BRIVIACT
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
205838
BRIVIACT
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
Back to Companies who have applied for FDA Drug Approval