FDA.reportPublic FDA data

Application 021997

Type
NDA
Sponsor
MYLAN SPECIALITY LP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EDLUARZOLPIDEM TARTRATETABLET;SUBLINGUAL5MGYesNo
002EDLUARZOLPIDEM TARTRATETABLET;SUBLINGUAL10MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0037-6010EdluarZolpidem TartrateMeda PharmaceuticalsNDACurrent
0037-6010EdluarZolpidem TartrateMeda Pharmaceuticals Inc.NDACurrent
0037-6010EdluarZolpidem TartrateMeda Pharmaceuticals Inc.NDACurrent
0037-6010EdluarZolpidem TartrateMeda PharmaceuticalsNDACurrent
0037-6010EdluarZolpidem TartrateMeda Pharmaceuticals Inc.NDACurrent
0037-6010EdluarZolpidem TartrateMeda Pharmaceuticals Inc.NDACurrent
0037-6010EdluarZolpidem TartrateMeda Pharmaceuticals Inc.NDACurrent
0037-6010EdluarZolpidem TartrateMeda PharmaceuticalsNDACurrent
0037-6050EdluarZolpidem TartrateMeda PharmaceuticalsNDACurrent
0037-6050EdluarZolpidem TartrateMeda Pharmaceuticals Inc.NDACurrent
0037-6050EdluarZolpidem TartrateMeda Pharmaceuticals Inc.NDACurrent
0037-6050EdluarZolpidem TartrateMeda PharmaceuticalsNDACurrent
0037-6050EdluarZolpidem TartrateMeda Pharmaceuticals Inc.NDACurrent
0037-6050EdluarZolpidem TartrateMeda Pharmaceuticals Inc.NDACurrent
0037-6050EdluarZolpidem TartrateMeda Pharmaceuticals Inc.NDACurrent
0037-6050EdluarZolpidem TartrateMeda PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59799SUPPL2019-08-21
59798SUPPL2019-08-21
59750SUPPL2019-08-20
57602SUPPL2019-02-14
57469SUPPL2019-02-07
56140SUPPL2018-10-29
56116SUPPL2018-10-26
38046SUPPL2014-11-04
6643SUPPL2014-10-30
6642SUPPL2013-04-24
38045SUPPL2013-04-23
6641SUPPL2011-09-20
6640SUPPL2010-12-21
44662ORIG2009-06-12
21899ORIG2009-06-12
16724ORIG2009-03-26
6639ORIG2009-03-19