FDA Approved Products
1,302 products with lifecycle intelligence, competitive pressure scores, and patent timelines.
OPANA ER
oxymorphone hydrochloride
Peak
ORAL · TABLET, EXTENDED RELEASE
2011
NDA8/100
OPSUMIT
macitentan
Peak
Johnson & Johnson
ORAL · TABLET
2013
NDA8/100
OSENI
alogliptin benzoate and pioglitazone hydrochloride
Peak
Takeda
ORAL · TABLET
type 2 diabetes mellitustype 1 diabetes mellitus
2013
NDA8/100
OTOVEL
ciprofloxacin hydrochloride; fluocinolone acetonide
Peak
Salvat
OTIC · SOLUTION/DROPS
2016
NDA8/100
OXYCONTIN
oxycodone hydrochloride
Peak
Purdue Pharma
ORAL · TABLET, EXTENDED RELEASE
severepersistent pain+1
2010
NDA8/100
PENNSAID
diclofenac sodium
Peak
Amgen
TOPICAL · SOLUTION
2014
NDA8/100
PENNSAID
diclofenac sodium
Peak
TOPICAL · SOLUTION
2009
NDA8/100
PHOSLYRA
calcium acetate
Peak
Fresenius Kabi
ORAL · SOLUTION
2011
NDA8/100
PLIAGLIS
lidocaine and tetracaine
Peak
Crescita Therapeutics
TOPICAL · CREAM
2006
NDA8/100
PRESTALIA
amlodipine besylate; perindopril arginine
Peak
ORAL · TABLET
2015
NDA8/100
QMIIZ ODT
meloxicam
Peak
TerSera Therapeutics
ORAL · TABLET, ORALLY DISINTEGRATING
2018
NDA8/100
QSYMIA
phentermine and topiramate
Peak
ORAL · CAPSULE, EXTENDED RELEASE
2012
NDA8/100
QTERN
dapagliflozin; saxagliptin hydrochloride
Peak
AstraZeneca
ORAL · TABLET
2017
NDA8/100
QUARTETTE
levonorgestrel/ethinyl estradiol and ethinyl estradiol
Peak
Teva
ORAL · TABLET
2013
NDA8/100
QUILLIVANT XR
methylphenidate hydrochloride
Peak
ORAL · FOR SUSPENSION, EXTENDED RELEASE
2012
NDA8/100
QUTENZA
capsaicin
Peak
TOPICAL · PATCH
2009
NDA8/100
QUZYTTIR
cetirizine hydrochloride
Peak
INTRAVENOUS · SOLUTION
2019
NDA8/100
RASUVO
methotrexate
Peak
Medexus Pharmaceuticals
SUBCUTANEOUS · SOLUTION
2014
NDA8/100
RELISTOR
methylnaltrexone bromide
Peak
Bausch Health
SUBCUTANEOUS · SOLUTION
2008
NDA8/100
REMODULIN
treprostinil
Peak
United Therapeutics
INTRAVENOUS, SUBCUTANEOUS · INJECTABLE
2002
NDA8/100
RENVELA
sevelamer carbonate
Peak
Sanofi
ORAL · FOR SUSPENSION
2009
NDA8/100
RUKOBIA
fostemsavir tromethamine
Peak
GSK
ORAL · TABLET, EXTENDED RELEASE
human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistanceintolerance+2
2020
NDA8/100
RYDAPT
rydapt
Peak
Novartis
ORAL · CAPSULE
2017
NDA8/100
SAFYRAL
drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium
Peak
Bayer
ORAL · TABLET
females of reproductive potentialto raise folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product+1
2010
NDA8/100