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Back to Companies who have applied for FDA Drug Approval
FDA Drug Approval Applications Sponsored by APIL
Application Number
Drugs/Products
Application Type
Most Recent Label Available Flag
Current Patent Flag
Action Type
Chemical Type
Ther Potential
Orphan Code
017060
NOR-QD
New Drug Application
Approval
New formulation
(S) Standard review drug
017354
LOESTRIN FE 1/20
New Drug Application
Approval
New formulation
(P) Priority review drug
017355
LOESTRIN FE 1.5/30
New Drug Application
Approval
New formulation
(P) Priority review drug
017831
DIDRONEL
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
017875
LOESTRIN 21 1.5/30
New Drug Application
Approval
New formulation
(S) Standard review drug
017876
LOESTRIN 21 1/20
New Drug Application
Approval
New formulation
(S) Standard review drug
019651
ASACOL
New Drug Application
Approval
New formulation
(P) Priority review drug
020130
ESTROSTEP 21
ESTROSTEP FE
New Drug Application
Approval
New formulation
(S) Standard review drug
020835
ACTONEL
New Drug Application
Approval
New molecular entity (NME)
021065
FEMHRT
New Drug Application
Approval
New formulation
(S) Standard review drug
021367
FEMRING
New Drug Application
Approval
New ester, new salt, or other noncovalent derivative
(S) Standard review drug
021490
FEMCON FE
New Drug Application
Approval
New formulation
(S) Standard review drug
021513
ENABLEX
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
021633
FEMTRACE
New Drug Application
Approval
New formulation
(S) Standard review drug
021830
ASACOL HD
New Drug Application
Approval
New formulation
(S) Standard review drug
021860
SARAFEM
New Drug Application
Approval
New formulation
(S) Standard review drug
021871
LOESTRIN 24 FE
New Drug Application
Approval
New formulation
(S) Standard review drug
022501
LO LOESTRIN FE
New Drug Application
Approval
New formulation
(S) Standard review drug
022560
ATELVIA
New Drug Application
Approval
New formulation
(S) Standard review drug
022573
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
New Drug Application
Approval
New manufacturer
(S) Standard review drug
203667
MINASTRIN 24 FE
New Drug Application
Approval
New manufacturer
(S) Standard review drug
204412
DELZICOL
New Drug Application
Approval
New formulation
(S) Standard review drug
204426
TAYTULLA
New Drug Application
Approval
New formulation
(S) Standard review drug
204654
LO MINASTRIN FE
New Drug Application
Approval
New manufacturer
(S) Standard review drug
Back to Companies who have applied for FDA Drug Approval