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Back to Companies who have applied for FDA Drug Approval
FDA Drug Approval Applications Sponsored by PFIZER
Application Number
Drugs/Products
Application Type
Most Recent Label Available Flag
Current Patent Flag
Action Type
Chemical Type
Ther Potential
Orphan Code
009127
CORTRIL
New Drug Application
Approval
New manufacturer
(S) Standard review drug
009164
CORTRIL
New Drug Application
Approval
New manufacturer
(S) Standard review drug
009996
STERANE
New Drug Application
Approval
New manufacturer
(S) Standard review drug
010392
ATARAX
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
010554
MAGNACORT
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
010686
MODERIL
New Drug Application
Approval
New manufacturer
(S) Standard review drug
011111
VISTARIL
New Drug Application
Approval
New formulation
(S) Standard review drug
011210
TESSALON
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
011446
STERANE
New Drug Application
Approval
New manufacturer
(S) Standard review drug
011459
VISTARIL
New Drug Application
Approval
New ester, new salt, or other noncovalent derivative
(S) Standard review drug
011612
DARICON
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
011641
DIABINESE
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
011795
VISTARIL
New Drug Application
Approval
New formulation
(S) Standard review drug
012128
FOVANE
URESE
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
012845
RENESE
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
013636
RENESE-R
New Drug Application
Approval
New combination
(S) Standard review drug
016584
NAVANE
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
016758
NAVANE
New Drug Application
Approval
New ester, new salt, or other noncovalent derivative
(S) Standard review drug
016798
SINEQUAN
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
016820
EMETE-CON
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
016834
LITHIUM CARBONATE
New Drug Application
Approval
New formulation
(S) Standard review drug
016904
NAVANE
New Drug Application
Approval
New ester, new salt, or other noncovalent derivative
(S) Standard review drug
017442
MINIPRESS
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
017516
SINEQUAN
New Drug Application
Approval
New formulation
(S) Standard review drug
017783
GLUCOTROL
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
017986
MINIZIDE
New Drug Application
Approval
New combination
(S) Standard review drug
018069
VANSIL
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
018147
FELDENE
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
018353
FLAGYL I.V.
FLAGYL I.V. RTU IN PLASTIC CONTAINER
New Drug Application
Approval
New formulation
(P) Priority review drug
018482
PROCARDIA
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
018682
TZ-3
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
018989
ADVIL
New Drug Application
Approval
New formulation
(P) Priority review drug
019152
CALAN SR
New Drug Application
Approval
New formulation
(S) Standard review drug
019440
UNISOM
New Drug Application
Approval
New formulation
(S) Standard review drug
019668
CARDURA
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
019684
PROCARDIA XL
New Drug Application
Approval
New formulation
(S) Standard review drug
019771
ADVIL COLD AND SINUS
New Drug Application
Approval
New combination
(S) Standard review drug
019775
MINIPRESS XL
New Drug Application
Approval
New formulation
(S) Standard review drug
019787
NORVASC
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
019839
ZOLOFT
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
019949
DIFLUCAN
New Drug Application
Approval
New molecular entity (NME)
(P*) Priority review drug*
019950
DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER
DIFLUCAN IN SODIUM CHLORIDE 0.9%
DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
New Drug Application
Approval
New formulation
(S*) Standard review drug*
020090
DIFLUCAN
New Drug Application
Approval
New formulation
(S*) Standard review drug*
020267
JUNIOR STRENGTH ADVIL
New Drug Application
Approval
New formulation
(S) Standard review drug
020329
GLUCOTROL XL
New Drug Application
Approval
New formulation
(S) Standard review drug
020402
ADVIL LIQUI-GELS
ADVIL MIGRAINE LIQUI-GELS
New Drug Application
Approval
New formulation
(S) Standard review drug
020555
AXID AR
New Drug Application
Approval
New formulation
(S) Standard review drug
020589
CHILDREN'S ADVIL
CHILDREN'S ADVIL-FLAVORED
New Drug Application
Approval
OTC (over-the-counter) switch
(S) Standard review drug
020702
LIPITOR
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
020755
CAVERJECT
New Drug Application
Approval
New manufacturer
(S) Standard review drug
020759
TROVAN
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
020760
TROVAN PRESERVATIVE FREE
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
020812
PEDIATRIC ADVIL
New Drug Application
Approval
New formulation
(S) Standard review drug
020825
GEODON
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
020859
SONATA
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
020883
ARGATROBAN
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
020919
GEODON
New Drug Application
Approval
New formulation
(S) Standard review drug
020931
TIKOSYN
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
020944
CHILDREN'S ADVIL
JUNIOR STRENGTH ADVIL
New Drug Application
Approval
New formulation
020990
ZOLOFT
New Drug Application
Approval
New formulation
(S) Standard review drug
021269
CARDURA XL
New Drug Application
Approval
New formulation
(S) Standard review drug
021373
CHILDREN'S ADVIL COLD
New Drug Application
Approval
New formulation
(S) Standard review drug
021374
ADVIL COLD AND SINUS
New Drug Application
Approval
New formulation
(S) Standard review drug
021375
ALAVERT
New Drug Application
Approval
New formulation
(S) Standard review drug
021393
ADVIL PM
New Drug Application
Approval
New combination
(S) Standard review drug
021394
ADVIL PM
New Drug Application
Approval
New combination
(S) Standard review drug
021441
ADVIL ALLERGY SINUS
New Drug Application
Approval
New combination
(S) Standard review drug
021464
VFEND
New Drug Application
Approval
New indication
(S) Standard review drug
021466
VFEND
New Drug Application
Approval
New indication
(S) Standard review drug
021540
CADUET
New Drug Application
Approval
New combination
(S) Standard review drug
021584
DEPO-SUBQ PROVERA 104
New Drug Application
Approval
New indication
(S) Standard review drug
021587
CHILDREN'S ADVIL ALLERGY SINUS
New Drug Application
Approval
New formulation
(S) Standard review drug
021845
REVATIO
New Drug Application
Approval
New manufacturer
(P) Priority review drug
021868
EXUBERA
New Drug Application
Approval
New formulation
(S) Standard review drug
021948
ERAXIS
New Drug Application
Approval
New indication
(P) Priority review drug
022030
TOVIAZ
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
022113
ADVIL ALLERGY AND CONGESTION RELIEF
New Drug Application
Approval
New combination
(S) Standard review drug
022458
ELELYSO
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
(V) Orphan drug
022473
REVATIO
New Drug Application
Approval
New formulation
(S) Standard review drug
022565
ADVIL CONGESTION RELIEF
New Drug Application
Approval
New combination
(S) Standard review drug
050006
VIBRAMYCIN
New Drug Application
Approval
050007
VIBRAMYCIN
New Drug Application
Approval
050109
MITHRACIN
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
050286
TERRAMYCIN
New Drug Application
Approval
050287
TERRAMYCIN
New Drug Application
Approval
050332
TAO
New Drug Application
Approval
050336
TAO
New Drug Application
Approval
050347
TROBICIN
New Drug Application
Approval
050435
GEOCILLIN
New Drug Application
Approval
050442
VIBRAMYCIN
New Drug Application
Approval
050480
VIBRAMYCIN
New Drug Application
Approval
New ester, new salt, or other noncovalent derivative
(S) Standard review drug
050520
SPECTROBID
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
050533
VIBRA-TABS
New Drug Application
Approval
New formulation
(S) Standard review drug
050551
CEFOBID
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
050556
SPECTROBID
New Drug Application
Approval
New formulation
(S) Standard review drug
050608
UNASYN
New Drug Application
Approval
New molecular entity (NME); New combination
(S) Standard review drug
050613
CEFOBID IN PLASTIC CONTAINER
New Drug Application
Approval
New formulation
(S) Standard review drug
050670
ZITHROMAX
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
050693
ZITHROMAX
New Drug Application
Approval
New formulation
(S) Standard review drug
050710
ZITHROMAX
New Drug Application
Approval
New formulation
(S) Standard review drug
050711
ZITHROMAX
New Drug Application
Approval
New formulation
(S) Standard review drug
050730
ZITHROMAX
New Drug Application
Approval
New formulation
(P) Priority review drug
050733
ZITHROMAX
New Drug Application
Approval
New formulation
(S) Standard review drug
050762
TROVAN/ZITHROMAX COMPLIANCE PAK
New Drug Application
Approval
New combination
(S) Standard review drug
050784
ZITHROMAX
New Drug Application
Approval
New formulation
(S) Standard review drug
060014
PERMAPEN
Abbreviated New Drug Application
Approval
060074
PENICILLIN G POTASSIUM
Abbreviated New Drug Application
Approval
060075
PFIZERPEN G
Abbreviated New Drug Application
Approval
060076
STREPTOMYCIN SULFATE
Abbreviated New Drug Application
Approval
060096
TETRACYN
Abbreviated New Drug Application
Approval
060099
PENICILLIN G PROCAINE
Abbreviated New Drug Application
Approval
060111
STREPTOMYCIN SULFATE
Abbreviated New Drug Application
Approval
060282
BACITRACIN
Abbreviated New Drug Application
Approval
060285
TETRACYN
Abbreviated New Drug Application
Approval
060286
PFIZERPEN-AS
Abbreviated New Drug Application
Approval
060475
NEOBIOTIC
Abbreviated New Drug Application
Approval
060567
TERRAMYCIN
Abbreviated New Drug Application
Approval
060586
TERRAMYCIN
Abbreviated New Drug Application
Approval
060587
PFIZERPEN G
Abbreviated New Drug Application
Approval
060595
TERRAMYCIN
Abbreviated New Drug Application
Approval
060657
PFIZERPEN
Abbreviated New Drug Application
Approval
061009
TERRAMYCIN-POLYMYXIN
Abbreviated New Drug Application
Approval
061015
TERRAMYCIN W/ POLYMYXIN B SULFATE
Abbreviated New Drug Application
Approval
061016
TERRA-CORTRIL
Abbreviated New Drug Application
Approval
061086
VIOCIN SULFATE
Abbreviated New Drug Application
Approval
061791
PFIZER-E
Abbreviated New Drug Application
Approval
061815
PFIZERPEN VK
Abbreviated New Drug Application
Approval
061836
PFIZERPEN VK
Abbreviated New Drug Application
Approval
061841
TERRAMYCIN W/ POLYMYXIN
Abbreviated New Drug Application
Approval
062049
PFIZERPEN-A
Abbreviated New Drug Application
Approval
062050
PFIZERPEN-A
Abbreviated New Drug Application
Approval
062901
UNASYN
Abbreviated New Drug Application
Approval
063333
CEFOBID
Abbreviated New Drug Application
Approval
075822
LORATADINE
Abbreviated New Drug Application
Approval
201370
HEPARIN SODIUM
HEPARIN SODIUM PRESERVATIVE FREE
New Drug Application
Approval
New manufacturer
(S) Standard review drug
203109
REVATIO
New Drug Application
Approval
New formulation
(P) Priority review drug
Back to Companies who have applied for FDA Drug Approval