spinosad Medicated Shampoo

Brand(s)
Natroba
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Parapro Llc (2015-05-27)
Oldest Current Product
2011-01-25
License(s)
NDA
RxNORM
MEDICATED SHAMPOO\SPINOSAD
FDAOB
TOPICAL\SUSPENSION\SPINOSAD
SPL Active
TOPICAL\SUSPENSION\SPINOSAD
SPL Moiety
TOPICAL\SUSPENSION\SPINOSAD

product(s) by strength(s)

spinosad 9 mg/ml medicated shampoo

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1441830900NDAMacoven Pharmaceuticals2012-07-18SPINOSADTOPICALSUSPENSIONNDA0224085cd2bff8-40cd-4e63-9907-77b80d774cb7
2522460929NatrobaNDAParapro Llc2011-01-25SPINOSADTOPICALSUSPENSIONNDA022408fa90ccc8-2df0-49f7-8878-2b33e34cd272

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA022408NATROBAPARAPRO LLC2011-01-18p6063771, NATROBA TOPICAL SUSPENSION IS A PEDICULICIDE INDICATED FOR THE TOPICAL TREATMENT OF HEAD LICE INFESTATION IN PATIENTS SIX (6) MONTHS OF AGE AND OLDER., SUBSTANCE
p6342482, TOPICAL TREATMENT OF HEAD LICE INFESTATION IN PATIENTS FOUR (4) YEARS OF AGE AND OLDER, SUBSTANCE
p7030095, TOPICAL TREATMENT OF HEAD LICE INFESTATION IN PATIENTS FOUR (4) YEARS OF AGE AND OLDER, SUBSTANCE
NEW CHEMICAL ENTITY [2016-01-18]
INFORMATION ADDED TO THE CLINICAL PHARMACOLOGY SECTION OF THE LABELING REGARDING A SAFETY STUDY IN PEDIATRIC SUBJECTS AGES 6 MONTHS TO 4 YEARS OF AGE WITH AN ACTIVE HEAD LICE INFESTATION [2017-11-30]
NDA022408_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022408_001RXSPINOSAD (0.9%)TOPICALSUSPENSIONTrue2011-01-18NATROBA

patent(s)

#idexpiration dateapplication(s)
1p6063771 (view patent)2023-07-25NDA022408
2p6342482 (view patent)2019-06-22NDA022408
3p7030095 (view patent)2021-07-02NDA022408

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
15cd2bff8-40cd-4e63-9907-77b80d774cb7 (view SPL)These highlights do not include all the information needed to use Spinosad Topical Suspension safely and effectively. See full prescribing information for Spinosad Topical Suspension. Spinosad Topical Suspension, 0.9%For topical useInitial U.S. Approval: 2011prescriptionHuman PrescriptionMacoven Pharmaceuticals2012-07-261441830900
28e87bd3b-db25-4e97-bf57-96c875f67ce1 (view SPL)These highlights do not include all the information needed to use Spinosad Topical Suspension safely and effectively. See full prescribing information for Spinosad Topical Suspension. Spinosad Topical Suspension, 0.9%, for topical use Initial U.S. Approval: 2011prescriptionHuman PrescriptionAllegis Pharmaceuticals, Llc2015-06-092285950570
3fa90ccc8-2df0-49f7-8878-2b33e34cd272 (view SPL)These highlights do not include all the information needed to use NATROBA Topical Suspension safely and effectively. See full prescribing information for NATROBA Topical Suspension. Natroba (spinosad) topical suspension, 0.9%For topical use Initial U.S. Approval: 2011prescriptionHuman PrescriptionParapro LlcLABEL, MANUFACTURE, PACK2015-05-276522460929

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