FDA Approved Products
1,302 products with lifecycle intelligence, competitive pressure scores, and patent timelines.
XOFIGO
radium ra 223 dichloride
Peak
Bayer
INTRAVENOUS · SOLUTION
symptomatic bone metastasesno known visceral metastatic disease+1
2013
NDA30/100
XTRELUS
guaifenesin; hydrocodone bitartrate
Peak
ORAL · TABLET
2018
NDA30/100
XURIDEN
uridine triacetate
Peak
ORAL · GRANULE
2015
NDA30/100
XYZAL ALLERGY 24HR
levocetirizine dihydrochloride
Peak
Sanofi
ORAL · TABLET
2017
NDA30/100
ZEGERID OTC
omeprazole; sodium bicarbonate
Peak
ORAL · FOR SUSPENSION
2013
NDA30/100
ZINC SULFATE
zinc sulfate
Peak
INTRAVENOUS · SOLUTION
2019
NDA30/100
ZOLEDRONIC ACID
zoledronic acid
Peak
Pfizer
INTRAVENOUS · SOLUTION
2015
NDA30/100
ZOLEDRONIC ACID
zoledronic acid
Peak
INTRAVENOUS · INJECTABLE
2013
NDA30/100
ZUTRIPRO
chlorpheniramine maleate; hydrocodone bitartrate; pseudoephedrine hydrochloride
Peak
ORAL · SOLUTION
2011
NDA30/100
ZYDELIG
idelalisib
Peak
Gilead Sciences
ORAL · TABLET
2014
SMNDA30/100
ACANYA
clindamycin phosphate and benzoyl peroxide
Peak
Bausch + Lomb
TOPICAL · GEL
2008
NDA8/100
ACETAMINOPHEN
acetaminophen
Peak
Fresenius Kabi
INTRAVENOUS · SOLUTION
mild to moderate pain in adultolder () Management of moderate to severe pain with adjunctive opioid analgesics in adult+2
2015
NDA8/100
ACUVAIL
ketorolac tromethamine
Peak
AbbVie
OPHTHALMIC · SOLUTION/DROPS
paininflammation following cataract surgery
2009
NDA8/100
ACUVUE THERAVISION WITH KETOTIFEN
ketotifen fumarate
Peak
Johnson & Johnson
OPHTHALMIC · DRUG-ELUTING CONTACT LENS
2022
NDA8/100
AIRSUPRA
albuterol sulfate and budesonide
Peak
AstraZeneca
INHALATION · AEROSOL, METERED
asthma
2023
NDA8/100
AMONDYS 45
casimersen
Peak
INTRAVENOUS · SOLUTION
Duchenne muscular dystrophy (DMD) in patients
2021
RNANDA8/100
ANORO ELLIPTA
umeclidinium bromide and vilanterol trifenatate
Peak
GSK
INHALATION · POWDER
COPDasthma+1
2013
NDA8/100
APRISO
mesalamine
Peak
Salix Pharmaceuticals
ORAL · CAPSULE, EXTENDED RELEASE
ulcerative colitis
2008
NDA8/100
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
Peak
Gilead Sciences
ORAL · TABLET
2006
NDA8/100
ATROVENT HFA
ipratropium bromide
Peak
Boehringer Ingelheim
INHALATION · AEROSOL, METERED
COPDchronic obstructive pulmonary disease
2004
NDA8/100
AURYXIA
ferric citrate
Peak
ORAL · TABLET
iron deficiency anemia in adult patients with chronic kidney disease not on dialysisanemia+1
2014
NDA8/100
BESIVANCE
besifloxacin
Peak
Bausch + Lomb
OPHTHALMIC · SUSPENSION/DROPS
bacterial conjunctivitis caused by susceptible isolates of the following bacteria: Aerococcus viridans*CDC coryneform group G+15
2009
SMNDA8/100
BEYAZ
drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium
Peak
Bayer
ORAL · TABLET
symptoms of premenstrual dysphoric disorder (PMDD) in females of reproductive potentialmoderate acne vulgaris in females of reproductive potential at least 14 years of age+6
2010
NDA8/100
BRISDELLE
paroxetine
Peak
Enterprise Therapeutics
ORAL · CAPSULE
any psychiatric conditionmoderate to severe vasomotor symptoms associated with menopause (VMS) () Limitation of Use: Paroxetine capsules are not indicated for the treatment of any psychiatric condition ()+2
2013
NDA8/100