FDA Approved Products
29,717 products with lifecycle intelligence, competitive pressure scores, and patent timelines.
AMOXICILLIN
amoxicillin
Post-LOE
Novartis
ORAL · FOR SUSPENSION
infections due to susceptible strains of designated microorganismsthe treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus species+4
2007
ANDA60/100
AMOXICILLIN
amoxicillin
Post-LOE
Novartis
ORAL · FOR SUSPENSION
infections due to susceptible strains of designated microorganismsthe treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus species+4
2007
ANDA60/100
AMOXICILLIN
amoxicillin
Post-LOE
Novartis
ORAL · CAPSULE
infections due to susceptible strains of designated microorganismsthe treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus species+4
1994
ANDA60/100
AMOXICILLIN AND CLAVULANATE POTASSIUM
amoxicillin and clavulanate potassium
Post-LOE
Novartis
ORAL · FOR SUSPENSION
acute otitis media due to Sequal to 40 kg with: • Recurrent+10
2007
ANDA60/100
AMOXICILLIN AND CLAVULANATE POTASSIUM
amoxicillin and clavulanate potassium
Post-LOE
Novartis
ORAL · TABLET, EXTENDED RELEASE
infections in adultsequal to 40 kg+12
2010
ANDA60/100
AMOXICILLIN AND CLAVULANATE POTASSIUM
amoxicillin and clavulanate potassium
Post-LOE
Novartis
ORAL · TABLET
the following infections in adultsskin structure infections • Urinary tract infections Limitations of Use+11
2005
ANDA60/100
AZITHROMYCIN
azithromycin
Post-LOE
Novartis
ORAL · TABLET
development of drug-resistant bacteriamaintain the effectiveness of azithromycin+3
2005
ANDA60/100
AZITHROMYCIN
azithromycin
Post-LOE
Novartis
ORAL · TABLET
Administration ()]Clinical Studies ()]+5
2005
ANDA60/100
AZITHROMYCIN
azithromycin
Post-LOE
Novartis
ORAL · TABLET
development of drug-resistant bacteriamaintain the effectiveness of azithromycin+3
2005
ANDA60/100
CEFTRIAXONE
ceftriaxone sodium
Post-LOE
Novartis
INTRAMUSCULAR, INTRAVENOUS · INJECTABLE
the following infectionsStaphylococcus aureus+7
2005
ANDA60/100
CEFTRIAXONE
ceftriaxone sodium
Post-LOE
Novartis
INJECTION · INJECTABLE
the following infectionsStaphylococcus aureus+7
2005
ANDA60/100
CEFTRIAXONE
ceftriaxone sodium
Post-LOE
Novartis
INJECTION · INJECTABLE
the following infectionsStaphylococcus aureus+7
2005
ANDA60/100
DEXAMETHASONE
dexamethasone
Post-LOE
Hikma
ORAL · SOLUTION
dermatomyositispolymyositis+9
1983
ANDA60/100
DEXAMETHASONE
dexamethasone
Post-LOE
Hikma
ORAL · TABLET
dermatomyositispolymyositis+9
1978
ANDA60/100
DEXAMETHASONE
dexamethasone
Post-LOE
Alvogen
ORAL · TABLET
dermatomyositispolymyositis+9
1983
ANDA60/100
DIGOXIN
digoxin
LOE Approaching
Hikma
ORAL · ELIXIR
mild to moderate heart failureheart failure+1
2004
NDA60/100
FLOVENT DISKUS 100
fluticasone propionate
LOE Approaching
GSK
INHALATION · POWDER
asthma
2000
NDA60/100
METHOTREXATE SODIUM
methotrexate
Post-LOE
Hikma
INJECTION · INJECTABLE
1986
ANDA60/100
METHOTREXATE SODIUM
methotrexate
Post-LOE
Hikma
INJECTION · INJECTABLE
1986
ANDA60/100
METHOTREXATE SODIUM PRESERVATIVE FREE
methotrexate
Post-LOE
Hikma
INJECTION · INJECTABLE
1986
ANDA60/100
METHOTREXATE SODIUM PRESERVATIVE FREE
methotrexate
Post-LOE
Hikma
INJECTION · INJECTABLE
1986
ANDA60/100
MYCOPHENOLATE MOFETIL
mycophenolate mofetil
Post-LOE
Hikma
ORAL · TABLET
organ rejectioncombination with other immunosuppressants+4
2008
ANDA60/100
MYCOPHENOLATE MOFETIL
mycophenolate mofetil
Post-LOE
Hikma
ORAL · CAPSULE
organ rejectioncombination with other immunosuppressants+4
2008
ANDA60/100
MYCOPHENOLATE MOFETIL
mycophenolate mofetil
Post-LOE
Novartis
ORAL · TABLET
organ rejectioncombination with other immunosuppressants+4
2008
ANDA60/100
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