FDA.reportPublic FDA data

Application 022196

Type
NDA
Sponsor
AYTU

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZOLPIMISTZOLPIDEM TARTRATESPRAY, METERED;ORAL5MG/SPRAYYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
58407-510ZolpiMISTZolpidem TartrateMagna Pharmaceuticals, Inc.NDACurrent
58407-510ZolpiMISTZolpidem TartrateMagna Pharmaceuticals, Inc.NDACurrent
69654-510ZOLPIMISTzolpidem tartrateAytu BioScience, Inc.NDACurrent
69654-510ZOLPIMISTzolpidem tartrateAytu BioScience, Inc.NDACurrent
69654-510ZOLPIMISTzolpidem tartrateAytu BioPharma, Inc.NDACurrent
69654-510ZOLPIMISTzolpidem tartrateAytu BioPharma, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59766SUPPL2019-08-20
59765SUPPL2019-08-20
59748SUPPL2019-08-20
57603SUPPL2019-02-14
57471SUPPL2019-02-07
23702ORIG2013-04-29
29389SUPPL2011-10-03
29388SUPPL2010-10-19
42443ORIG2009-07-22
24257ORIG2009-07-22
17068ORIG2009-01-06
29387ORIG2008-12-29