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Back to Companies who have applied for FDA Drug Approval
FDA Drug Approval Applications Sponsored by MONARCH PHARMS
Application Number
Drugs/Products
Application Type
Most Recent Label Available Flag
Current Patent Flag
Action Type
Chemical Type
Ther Potential
Orphan Code
009818
KEMADRIN
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
017376
SEPTRA
SEPTRA DS
New Drug Application
Approval
New molecular entity (NME); New combination
(P) Priority review drug
017598
SEPTRA
SEPTRA GRAPE
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017943
PROLOPRIM
New Drug Application
Approval
New formulation
(S) Standard review drug
018299
VIROPTIC
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
018452
SEPTRA
New Drug Application
Approval
New manufacturer
(S) Standard review drug
050168
CORTISPORIN
New Drug Application
Approval
050169
CORTISPORIN
New Drug Application
Approval
050218
CORTISPORIN
New Drug Application
Approval
050479
CORTISPORIN
New Drug Application
Approval
New manufacturer
(S) Standard review drug
060582
NEOSPORIN
Abbreviated New Drug Application
Approval
060707
NEOSPORIN G.U. IRRIGANT
Abbreviated New Drug Application
Approval
061229
POLYSPORIN
Abbreviated New Drug Application
Approval
062822
PEDIOTIC
Abbreviated New Drug Application
Approval
083011
DERMACORT
PROCTOCORT
Abbreviated New Drug Application
Approval
084948
MENEST
Abbreviated New Drug Application
Approval
084949
MENEST
Abbreviated New Drug Application
Approval
084950
MENEST
Abbreviated New Drug Application
Approval
084951
MENEST
Abbreviated New Drug Application
Approval
087563
QUIBRON-T/SR
Abbreviated New Drug Application
Approval
088051
THALITONE
Abbreviated New Drug Application
Approval
088656
QUIBRON-T
Abbreviated New Drug Application
Approval
Back to Companies who have applied for FDA Drug Approval