FDA Approved Products
99 products with lifecycle intelligence, competitive pressure scores, and patent timelines.
QUIOFIC
folic acid
Launch
ORAL · SOLUTION
2026
NDA30/100
ROCURONIUM BROMIDE
rocuronium bromide
Launch
Fresenius Kabi
INTRAVENOUS · SOLUTION
2025
NDA30/100
SDAMLO
amlodipine
Launch
BrilliantStrings Therapeutics
ORAL · FOR SOLUTION
2025
SMNDA30/100
VYSCOXA
celecoxib
Launch
Inpharmus
ORAL · SUSPENSION
2025
SMNDA30/100
YUVIWEL
navepegritide
Launch
Ascendis Pharma
SUBCUTANEOUS · POWDER
2026
PeptideNDA30/100
ADQUEY
adquey
Launch
Acrotech Biopharma
TOPICAL · OINTMENT
atopic dermatitis
2026
NDA18/100
ZYCUBO
copper histidinate
Launch
Sentynl Therapeutics
SUBCUTANEOUS · POWDER
2026
NDA18/100
ZUSDURI
mitomycin
Launch
NeuroGenesis Bio
INTRAVESICAL · POWDER
2025
NDA8/100
ANZUPGO
delgocitinib
Launch
Leo Pharma
TOPICAL · CREAM
2025
SMNDA0/100
ARYNTA
lisdexamfetamine dimesylate
Launch
R-Pharm US
ORAL · SOLUTION
(): Attention Deficit Hyperactivity Disorder (ADHD) in adultsolder () Lisdexamfetamine dimesylate capsules are not indicated for weight loss
2025
NDA0/100
ATMEKSI
methocarbamol
Launch
ORAL · SUSPENSION
2025
NDA0/100
ATZUMI
dihydroergotamine mesylate
Launch
Satsuma Pharmaceuticals
NASAL · POWDER
hemiplegic migrainemigraine with brainstem aura+1
2025
NDA0/100
AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)
avutometinib potassium and defactinib hydrochloride
Launch
Verastem Oncology
ORAL · CAPSULE, TABLET
ovarian cancer
2025
NDA0/100
BLUJEPA
gepotidacin
Launch
GSK
ORAL · TABLET
female adultolder weighing at least 40 kilograms (kg) for the treatment of uncomplicated urinary tract infections (uUTI) caused by the following susceptible microorganisms: Escherichia coli+6
2025
NDA0/100
BREKIYA (AUTOINJECTOR)
dihydroergotamine mesylate
Launch
SUBCUTANEOUS · SOLUTION
hemiplegic migrainemigraine with brainstem aura+1
2025
NDA0/100
BRINSUPRI
brensocatib
Launch
Insmed
ORAL · TABLET
non-cystic fibrosis bronchiectasis in adultolder
2025
NDA0/100
BRUKINSA
zanubrutinib
Launch
BeOne Medicines
ORAL · CAPSULE
refractory marginal zone lymphoma (MZL)refractory follicular lymphoma (FL)+5
2025
SMNDA0/100
CARDAMYST
etripamil
Launch
Milestone Pharmaceuticals
NASAL · SPRAY
2025
NDA0/100
CLOTIC
clotrimazole
Launch
Inpharmus
OTIC · SOLUTION/DROPS
fungal otitis externa (otomycosis) due to Aspergillus speciesolder
2025
SMNDA0/100
CONTEPO
fosfomycin disodium
Launch
INTRAVENOUS · POWDER
older with complicated urinary tract infections (cUTI)including acute pyelonephritis+2
2025
NDA0/100
CYKLX
articaine hydrochloride
Launch
Genomics
OPHTHALMIC · SOLUTION/DROPS
2025
NDA0/100
DAWNZERA (AUTOINJECTOR)
donidalorsen
Launch
Ionis Pharmaceuticals
SUBCUTANEOUS · SOLUTION
2025
RNANDA0/100
DAYBUE STIX
trofinetide
Launch
Acadia Pharmaceuticals
ORAL · FOR SOLUTION
Rett syndrome in adultsolder
2025
PeptideNDA0/100
EKTERLY
sebetralstat
Launch
KalVista Pharmaceuticals
ORAL · TABLET
acute attacks of hereditary angioedema (HAE) in adultolder
2025
SMNDA0/100