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Back to Companies who have applied for FDA Drug Approval
FDA Drug Approval Applications Sponsored by SHIRE
Application Number
Drugs/Products
Application Type
Most Recent Label Available Flag
Current Patent Flag
Action Type
Chemical Type
Ther Potential
Orphan Code
005795
FURACIN
New Drug Application
Approval
New formulation
(S) Standard review drug
007390
BANTHINE
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
008732
PRO-BANTHINE
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
011270
FUROXONE
New Drug Application
Approval
New formulation
(S) Standard review drug
011323
FUROXONE
New Drug Application
Approval
New combination
(S) Standard review drug
012359
SALUTENSIN
SALUTENSIN-DEMI
New Drug Application
Approval
New combination
(S) Standard review drug
012892
URACIL MUSTARD
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
016913
DOPAR
New Drug Application
Approval
New manufacturer
(S) Standard review drug
019753
ETHMOZINE
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
019836
SUPPRELIN
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
(V) Orphan drug
020049
PENTASA
New Drug Application
Approval
New formulation
(P) Priority review drug
020712
CARBATROL
New Drug Application
Approval
New formulation
(S) Standard review drug
021303
ADDERALL XR 10
ADDERALL XR 15
ADDERALL XR 20
ADDERALL XR 25
ADDERALL XR 30
ADDERALL XR 5
New Drug Application
Approval
New formulation
(S) Standard review drug
022000
LIALDA
New Drug Application
Approval
New formulation
(S) Standard review drug
022037
INTUNIV
New Drug Application
Approval
New formulation
(S) Standard review drug
050493
TOPICYCLINE
New Drug Application
Approval
New formulation
(S) Standard review drug
083789
FURACIN
Abbreviated New Drug Application
Approval
083791
FURACIN
Abbreviated New Drug Application
Approval
084051
DEXTROSTAT
Abbreviated New Drug Application
Approval
087628
ANOQUAN
Abbreviated New Drug Application
Approval
125151
ELAPRASE
Biologic License Application
Approval
Back to Companies who have applied for FDA Drug Approval