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Back to Companies who have applied for FDA Drug Approval
FDA Drug Approval Applications Sponsored by BAYER HEALTHCARE LLC
Application Number
Drugs/Products
Application Type
Most Recent Label Available Flag
Current Patent Flag
Action Type
Chemical Type
Ther Potential
Orphan Code
007638
CHLOR-TRIMETON
New Drug Application
Approval
New formulation
(S) Standard review drug
017717
GYNE-LOTRIMIN
New Drug Application
Approval
018052
GYNE-LOTRIMIN
New Drug Application
Approval
New formulation
(S) Standard review drug
018182
MYCELEX-7
New Drug Application
Approval
New manufacturer
(S) Standard review drug
018183
MYCELEX
New Drug Application
Approval
New manufacturer
(S) Standard review drug
018230
MYCELEX-7
New Drug Application
Approval
New manufacturer
(S) Standard review drug
018397
CHLOR-TRIMETON
New Drug Application
Approval
New manufacturer
(S) Standard review drug
018471
OCUCLEAR
New Drug Application
Approval
New formulation
(S) Standard review drug
019658
CLARITIN
CLARITIN HIVES RELIEF
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
019670
CLARITIN-D
New Drug Application
Approval
New combination
(S) Standard review drug
020045
SHADE UVAGUARD
New Drug Application
Approval
New combination
(S) Standard review drug
020289
GYNE-LOTRIMIN COMBINATION PACK
New Drug Application
Approval
New formulation
(S) Standard review drug
020389
MYCELEX-7 COMBINATION PACK
New Drug Application
Approval
New manufacturer
(S) Standard review drug
020470
CLARITIN-D 24 HOUR
New Drug Application
Approval
New formulation
(S) Standard review drug
020525
GYNE-LOTRIMIN 3
New Drug Application
Approval
OTC (over-the-counter) switch
(S) Standard review drug
020526
GYNE-LOTRIMIN 3 COMBINATION PACK
New Drug Application
Approval
OTC (over-the-counter) switch
(S) Standard review drug
020574
GYNE-LOTRIMIN 3
New Drug Application
Approval
New formulation
(S) Standard review drug
020641
CLARITIN
CLARITIN HIVES RELIEF
New Drug Application
Approval
New formulation
(S) Standard review drug
020704
CLARITIN HIVES RELIEF REDITAB
CLARITIN REDITABS
New Drug Application
Approval
New formulation
(S) Standard review drug
021043
RID MOUSSE
New Drug Application
Approval
New formulation
(S) Standard review drug
021307
LOTRIMIN ULTRA
New Drug Application
Approval
OTC (over-the-counter) switch
(S) Standard review drug
021891
CHILDREN'S CLARITIN
New Drug Application
Approval
New formulation
(S) Standard review drug
021952
CLARITIN
New Drug Application
Approval
New formulation
(S) Standard review drug
021993
CLARITIN REDITABS
New Drug Application
Approval
New manufacturer
(S) Standard review drug
022015
MIRALAX
New Drug Application
Approval
OTC (over-the-counter) switch
(S) Standard review drug
022281
ZEGERID OTC
New Drug Application
Approval
OTC (over-the-counter) switch
(S) Standard review drug
022283
ZEGERID OTC
New Drug Application
Approval
OTC (over-the-counter) switch
(S) Standard review drug
Back to Companies who have applied for FDA Drug Approval