FDA.reportPublic FDA data

Application 203340

Type
NDA
Sponsor
ARBOR PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NYMALIZENIMODIPINESOLUTION;ORAL60MG/20MLYesYes
002NYMALIZENIMODIPINESOLUTION;ORAL6MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24338-200NymalizenimodipineArbor PharmaceuticalsNDACurrent
24338-200NymalizenimodipineArbor PharmaceuticalsNDACurrent
24338-200NymalizenimodipineArbor PharmaceuticalsNDACurrent
24338-205NymalizenimodipineArbor PharmaceuticalsNDACurrent
24338-205NymalizenimodipineArbor PharmaceuticalsNDACurrent
24338-205NymalizenimodipineArbor PharmaceuticalsNDACurrent
24338-230NymalizenimodipineArbor PharmaceuticalsNDACurrent
24338-230NymalizenimodipineAzurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)NDACurrent
24338-230NymalizenimodipineArbor PharmaceuticalsNDACurrent
24338-230NymalizenimodipineArbor PharmaceuticalsNDACurrent
24338-230NymalizenimodipineArbor PharmaceuticalsNDACurrent
24338-260NymalizenimodipineArbor PharmaceuticalsNDACurrent
24338-260NymalizenimodipineAzurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)NDACurrent
24338-260NymalizenimodipineArbor PharmaceuticalsNDACurrent
24338-260NymalizenimodipineArbor PharmaceuticalsNDACurrent
24338-260NymalizenimodipineArbor PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79888SUPPL 2024-10-15
79883SUPPL 2024-10-15
68778SUPPL2021-09-24
65707SUPPL2020-12-23
65701SUPPL2020-12-23
62857SUPPL2020-05-08
62535SUPPL2020-04-10
61548SUPPL2020-01-10
43428ORIG2014-03-06
24431ORIG2014-03-06
32411ORIG2013-05-14
19457ORIG2013-05-10