Nimodipine Oral Solution

Brand(s)
Nymalize
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Arbor Pharmaceuticals, Inc. (2014-05-01)
Oldest Current Product
2013-06-03
License(s)
NDA
RxNORM
ORAL SOLUTION\NIMODIPINE
FDAOB
ORAL\SOLUTION\NIMODIPINE
SPL Active
ORAL\SOLUTION\NIMODIPINE
SPL Moiety
ORAL\SOLUTION\NIMODIPINE

product(s) by strength(s)

nimodipine 3 mg/ml oral solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1243380200NymalizeNDAArbor Pharmaceuticals, Inc.2013-06-03NIMODIPINEORALSOLUTIONNDA2033409e48dba7-c706-44fc-b04b-0fdcb2d72bc4

application(s)

#idtitleapplicantapprovedexclusivityapproved drug
1NDA203340NYMALIZEARBOR PHARMACEUTICALS LLC2013-05-10ORPHAN DRUG EXCLUSIVITY [2020-05-10]NDA203340_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203340_001RXNIMODIPINE (60MG/20ML)ORALSOLUTIONTrue2013-05-10NYMALIZE

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
19e48dba7-c706-44fc-b04b-0fdcb2d72bc4 (view SPL)These highlights do not include all the information needed to use NYMALIZE safely and effectively. See full prescribing information for NYMALIZE. NYMALIZE (nimodipine) oral solutionInitial U.S. Approval: 1988prescriptionHuman PrescriptionArbor Pharmaceuticals, Inc.2014-05-013243380200

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII