FDA Approved Products
1,302 products with lifecycle intelligence, competitive pressure scores, and patent timelines.
ASCOR
ascorbic acid
Peak
INTRAVENOUS · SOLUTION
vitamin C deficiencysymptoms of scurvy
2017
NDA30/100
ASMANEX HFA
mometasone furoate
Peak
Merck & Co.
INHALATION · AEROSOL, METERED
asthma
2014
NDA30/100
ASTAGRAF XL
tacrolimus extended-release capsules
Peak
Astellas
ORAL · CAPSULE, EXTENDED RELEASE
organ rejection in kidney transplant patients in combination with other immunosuppressants in adult
2013
NDA30/100
ATROPINE (AUTOINJECTOR)
atropine injection, 2 mg
Peak
INTRAMUSCULAR · SOLUTION
poisoning by susceptible organophosphorus nerve agents having anticholinesterase activitycarbamate insecticides in adults
2018
NDA30/100
ATROPINE SULFATE
atropine sulfate
Peak
Bausch + Lomb
OPHTHALMIC · SOLUTION/DROPS
2022
NDA30/100
ATROPINE SULFATE
atropine sulfate
Peak
Accord Biopharma
INTRAVENOUS · SOLUTION
older for: Atropine is an anticholinergic agent indicated in adultsolder for: Cycloplegia () Mydriasis () Penalization of the healthy eye in the treatment of amblyopia () 1
2020
NDA30/100
ATROPINE SULFATE
atropine sulfate
Peak
OPHTHALMIC · SOLUTION/DROPS
older for: Atropine is an anticholinergic agent indicated in adultsolder for: Cycloplegia () Mydriasis () Penalization of the healthy eye in the treatment of amblyopia () 1
2014
NDA30/100
ATROPINE SULFATE
atropine sulfate
Peak
Fresenius Kabi
INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL · SOLUTION
2018
NDA30/100
AUSTEDO
deutetrabenazine
Peak
Teva
ORAL · TABLET
2017
NDA30/100
AVACLYR
acyclovir
Peak
OPHTHALMIC · OINTMENT
the treatment of acute herpetic keratitis (dendritic ulcers) in patients with herpes simplex (HSV-1HSV-2) virus
2019
SMNDA30/100
AZACITIDINE
azacitidine
Peak
Teva
INTRAVENOUS, SUBCUTANEOUS · POWDER
refractory anemia with ringed sideroblasts (if accompanied by neutropeniathrombocytopenia+6
2016
NDA30/100
AZEDRA
iobenguane i-131
Peak
Progenicyte Therapeutics
INTRAVENOUS · SOLUTION
2018
NDA30/100
BENDAMUSTINE HYDROCHLORIDE
bendamustine hydrochloride
Peak
Pfizer
INTRAVENOUS · SOLUTION
within six months of treatment with rituximaba rituximab-containing regimen+2
2022
NDA30/100
BENDAMUSTINE HYDROCHLORIDE
bendamustine hydrochloride
Peak
Baxter
INTRAVENOUS · SOLUTION
within six months of treatment with rituximaba rituximab-containing regimen+2
2022
NDA30/100
BENDAMUSTINE HYDROCHLORIDE
bendamustine hydrochloride
Peak
INTRAVENOUS · SOLUTION
within six months of treatment with rituximaba rituximab-containing regimen+1
2022
NDA30/100
BENZNIDAZOLE
benznidazole
Peak
ORAL · TABLET
caused by Trypanosoma cruzi ( )
2017
SMNDA30/100
BETHKIS
tobramycin inhalation
Peak
Chiesi
INHALATION · SOLUTION
cystic fibrosis patients with Pseudomonas aeruginosa
2012
NDA30/100
BIORPHEN
phenylephrine hydrochloride
Peak
Dr. Reddy's Laboratories
INTRAVENOUS · SOLUTION
clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia
2019
NDA30/100
BIVALIRUDIN IN 0.9% SODIUM CHLORIDE
bivalirudin
Peak
Baxter
INTRAVENOUS · SOLUTION
2017
NDA30/100
BLOXIVERZ
neostigmine methylsulfate
Peak
INTRAVENOUS · SOLUTION
2013
NDA30/100
BONSITY
teriparatide
Peak
Alvogen
SUBCUTANEOUS · SOLUTION
women with osteoporosis associated with sustained systemic glucocorticoid therapy (daily dosage equivalent to 5 mggreater of prednisone) at high risk for fracture+2
2019
PeptideNDA30/100
BORTEZOMIB
bortezomib
Peak
Pfizer
INTRAVENOUS, SUBCUTANEOUS · POWDER
myelomalymphoma
2022
NDA30/100
BORTEZOMIB
bortezomib
Peak
Accord Biopharma
INTRAVENOUS · SOLUTION
myelomalymphoma
2022
NDA30/100
BORTEZOMIB
bortezomib
Peak
Dr. Reddy's Laboratories
INTRAVENOUS · POWDER
myelomalymphoma
2019
NDA30/100