FDA Approved Products
1,302 products with lifecycle intelligence, competitive pressure scores, and patent timelines.
BRIVIACT
brivaracetam
Peak
UCB Pharma
ORAL · TABLET
partial-onset seizures in patients 1 month of ageolder
2016
NDA8/100
BROMSITE
bromfenac
Peak
Fosun Pharma
OPHTHALMIC · SOLUTION/DROPS
postoperative inflammationprevention of ocular pain in patients undergoing cataract surgery
2016
NDA8/100
CHILDREN'S ALLEGRA ALLERGY
fexofenadine hydrochloride
Peak
Sanofi
ORAL · SUSPENSION
these symptoms due to hay feverother upper respiratory allergies: runny nose sneezing itchy+2
2011
NDA8/100
CHILDREN'S ALLEGRA HIVES
fexofenadine hydrochloride
Peak
Sanofi
ORAL · SUSPENSION
these symptoms due to hay feverother upper respiratory allergies: runny nose sneezing itchy+2
2011
NDA8/100
COMBIVENT RESPIMAT
ipratropium bromide and albuterol
Peak
Boehringer Ingelheim
INHALATION · SPRAY, METERED
chronic obstructive pulmonary diseaseCOPD
2011
NDA8/100
CUBICIN
daptomycin
Peak
INTRAVENOUS · POWDER
pneumonialeft-sided infective endocarditis due to S+13
2003
NDA8/100
CUBICIN RF
daptomycin
Peak
INTRAVENOUS · POWDER
pneumonialeft-sided infective endocarditis due to S+13
2003
NDA8/100
DESYREL
trazodone hydrochloride
Peak
Pragma Bio
ORAL · TABLET
major depressive disorder (MDD) ( )
1981
NDA8/100
DEXILANT SOLUTAB
dexlansoprazole
Peak
Takeda
ORAL · TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
older for: Healing of all grades of erosive esophagitis (EE)older for healing of all grades of erosive esophagitis (EE) for up to eight weeks+4
2016
SMNDA8/100
DOVATO
dolutegravir sodium and lamivudine
Peak
GSK
ORAL · TABLET
2019
NDA8/100
DUAKLIR PRESSAIR
aclidinium bromide and formoterol fumarate
Peak
INHALATION · POWDER, METERED
chronic obstructive pulmonary diseaseCOPD+1
2019
NDA8/100
DUTREBIS
lamivudine; raltegravir potassium
Peak
Merck & Co.
ORAL · TABLET
HIV-1 infection in adultsweighing at least 6 kg
2015
NDA8/100
ELLA
ulipristal acetate
Peak
ORAL · TABLET
pregnancy following unprotected intercoursea known+1
2010
NDA8/100
EMBEDA
morphine sulfate; naltrexone hydrochloride
Peak
ORAL · CAPSULE, EXTENDED RELEASE
moderate to severe painaround-the-clock opioid analgesic is needed for an extended period of time
2009
NDA8/100
ENTEREG
alvimopan
Peak
ORAL · CAPSULE
2008
NDA8/100
EUCRISA
crisaborole
Peak
R-Pharm US
TOPICAL · OINTMENT
atopic dermatitis
2016
NDA8/100
FABIOR
tazarotene
Peak
TOPICAL · AEROSOL, FOAM
2012
NDA8/100
FERRIPROX
deferiprone
Peak
Chiesi
ORAL · SOLUTION
2015
NDA8/100
FILSPARI
sparsentan
Peak
Travere Therapeutics
ORAL · TABLET
2023
NDA8/100
FLOLIPID
simvastatin
Peak
ORAL · SUSPENSION
2016
SMNDA8/100
FOSRENOL
lanthanum carbonate
Peak
Takeda
ORAL · POWDER
serum phosphate in patients with end-stage renal disease (ESRD)
2014
NDA8/100
GILOTRIF
afatinib
Peak
Boehringer Ingelheim
ORAL · TABLET
2013
SMNDA8/100
HORIZANT
gabapentin enacarbil
Peak
R-Pharm US
ORAL · TABLET, EXTENDED RELEASE
moderate-to-severe primary Restless Legs Syndrome (RLS) in adultspostherpetic neuralgia (PHN) in adults
2011
NDA8/100
IMPLANON
etonogestrel
Peak
Merck & Co.
IMPLANTATION · IMPLANT
pregnancy in women of reproductive potential for up to 5 years
2006
NDA8/100