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Back to Companies who have applied for FDA Drug Approval
FDA Drug Approval Applications Sponsored by MYLAN SPECLT
Application Number
Drugs/Products
Application Type
Most Recent Label Available Flag
Current Patent Flag
Action Type
Chemical Type
Ther Potential
Orphan Code
019430
EPI E Z PEN JR
EPIPEN
EPIPEN E Z PEN
EPIPEN JR.
New Drug Application
Approval
New manufacturer
(S) Standard review drug
020949
ACCUNEB
New Drug Application
Approval
New manufacturer
(S) Standard review drug
020950
DUONEB
New Drug Application
Approval
New combination
(S) Standard review drug
022007
PERFOROMIST
New Drug Application
Approval
New formulation
(S) Standard review drug
070804
METAPROTERENOL SULFATE
Abbreviated New Drug Application
Approval
071786
METAPROTERENOL SULFATE
Abbreviated New Drug Application
Approval
072652
ALBUTEROL SULFATE
Abbreviated New Drug Application
Approval
074209
CROMOLYN SODIUM
Abbreviated New Drug Application
Approval
074755
IPRATROPIUM BROMIDE
Abbreviated New Drug Application
Approval
075552
IPRATROPIUM BROMIDE
Abbreviated New Drug Application
Approval
075553
IPRATROPIUM BROMIDE
Abbreviated New Drug Application
Approval
077800
LEVALBUTEROL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
078309
LEVALBUTEROL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
Back to Companies who have applied for FDA Drug Approval