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Back to Companies who have applied for FDA Drug Approval
FDA Drug Approval Applications Sponsored by ASTRAZENECA
Application Number
Drugs/Products
Application Type
Most Recent Label Available Flag
Current Patent Flag
Action Type
Chemical Type
Ther Potential
Orphan Code
008048
XYLOCAINE
New Drug Application
Approval
New ester, new salt, or other noncovalent derivative
(S) Standard review drug
009925
DYCLONE
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
010418
XYLOCAINE
XYLOCAINE W/ EPINEPHRINE
New Drug Application
Approval
New manufacturer
(S) Standard review drug
010496
XYLOCAINE 5% W/ GLUCOSE 7.5%
New Drug Application
Approval
New combination
(S) Standard review drug
012703
ELAVIL
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
012704
ELAVIL
New Drug Application
Approval
New formulation
(S) Standard review drug
013077
XYLOCAINE
New Drug Application
Approval
New combination
(S) Standard review drug
014127
XYLOCAINE
New Drug Application
Approval
New formulation
(P) Priority review drug
014394
XYLOCAINE
New Drug Application
Approval
New formulation
(S) Standard review drug
014763
CITANEST
CITANEST FORTE
CITANEST PLAIN
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
016191
SORBITRATE
New Drug Application
Approval
New manufacturer
(S) Standard review drug
016192
SORBITRATE
New Drug Application
Approval
New manufacturer
(S) Standard review drug
016776
SORBITRATE
New Drug Application
Approval
New formulation
(S) Standard review drug
017751
DURANEST
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
017970
NOLVADEX
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
018257
TONOCARD
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
018555
YUTOPAR
New Drug Application
Approval
New manufacturer
(S) Standard review drug
018580
YUTOPAR
New Drug Application
Approval
New manufacturer
(S) Standard review drug
019058
TENORMIN
New Drug Application
Approval
New formulation
(P) Priority review drug
019082
DALGAN
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
019726
ZOLADEX
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
019834
PLENDIL
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
020233
RHINOCORT
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
020441
PULMICORT
New Drug Application
Approval
New formulation
(S) Standard review drug
020498
CASODEX
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
020541
ARIMIDEX
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
020578
ZOLADEX
New Drug Application
Approval
New formulation
(S) Standard review drug
020668
LEXXEL
New Drug Application
Approval
New combination
(S) Standard review drug
020838
ATACAND
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
020962
EMLA
New Drug Application
Approval
New formulation
(S) Standard review drug
021093
ATACAND HCT
New Drug Application
Approval
New combination
(S) Standard review drug
021231
ZOMIG-ZMT
New Drug Application
Approval
New formulation
(S) Standard review drug
021344
FASLODEX
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
021399
IRESSA
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
021450
ZOMIG
New Drug Application
Approval
New formulation
(S) Standard review drug
021929
SYMBICORT
New Drug Application
Approval
New combination
(S) Standard review drug
021949
PULMICORT FLEXHALER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
022047
SEROQUEL XR
New Drug Application
Approval
New formulation
022172
SEROQUEL XR
New Drug Application
Approval
New indication
(S) Standard review drug
022214
ARIMIDEX
New Drug Application
Approval
New indication
(P) Priority review drug
022310
CASODEX
New Drug Application
Approval
New indication
(P) Priority review drug
050706
MERREM
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
070014
FUROSEMIDE
Abbreviated New Drug Application
Approval
071018
METAPROTERENOL SULFATE
Abbreviated New Drug Application
Approval
071151
BRETYLIUM TOSYLATE
Abbreviated New Drug Application
Approval
071152
BRETYLIUM TOSYLATE
Abbreviated New Drug Application
Approval
071153
BRETYLIUM TOSYLATE
Abbreviated New Drug Application
Approval
071275
METAPROTERENOL SULFATE
Abbreviated New Drug Application
Approval
072018
DROPERIDOL
Abbreviated New Drug Application
Approval
072026
FENTANYL CITRATE AND DROPERIDOL
Abbreviated New Drug Application
Approval
072027
FENTANYL CITRATE AND DROPERIDOL
Abbreviated New Drug Application
Approval
072028
FENTANYL CITRATE AND DROPERIDOL
Abbreviated New Drug Application
Approval
072081
NALOXONE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
083080
AQUASOL A
Abbreviated New Drug Application
Approval
086405
SORBITRATE
Abbreviated New Drug Application
Approval
087937
ISOETHARINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
087938
ISOETHARINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088124
SORBITRATE
Abbreviated New Drug Application
Approval
088125
SORBITRATE
Abbreviated New Drug Application
Approval
088470
ISOETHARINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088471
ISOETHARINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088472
ISOETHARINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
089614
ISOETHARINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
089615
ISOETHARINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
089616
ISOETHARINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
089617
ISOETHARINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
089618
ISOETHARINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
Back to Companies who have applied for FDA Drug Approval