FDA.reportPublic FDA data

Application 207916

Type
NDA
Sponsor
ARBOR PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CETYLEVACETYLCYSTEINETABLET, EFFERVESCENT;ORAL500MGYesNo
002CETYLEVACETYLCYSTEINETABLET, EFFERVESCENT;ORAL2.5GMYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24338-700CetylevacetylcysteineArbor PharmaceuticalsNDACurrent
24338-707CetylevacetylcysteineArbor PharmaceuticalsNDACurrent
24338-725CetylevacetylcysteineArbor PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48066SUPPL2017-04-19
48065SUPPL2017-04-19
45885ORIG2016-11-10
19970ORIG2016-02-11
10624ORIG2016-02-02