FDA.reportPublic FDA data

Application 021937

Type
NDA
Sponsor
GILEAD SCIENCES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATRIPLAEFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATETABLET;ORAL600MG;200MG;300MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
15584-0101Atriplaefavirenz, emtricitabine, and tenofovir disoproxil fumarateGilead Sciences, LLCNDACurrent
15584-0101Atriplaefavirenz, emtricitabine, and tenofovir disoproxil fumarateGilead Sciences, LLCNDACurrent
15584-0101Atriplaefavirenz, emtricitabine, and tenofovir disoproxil fumarateGilead Sciences, LLCNDACurrent
15584-0101Atriplaefavirenz, emtricitabine, and tenofovir disoproxil fumarateGilead Sciences, LLCNDACurrent
15584-0101Atriplaefavirenz, emtricitabine, and tenofovir disoproxil fumarateGilead Sciences, LLCNDACurrent
50090-0980Atriplaefavirenz, emtricitabine, and tenofovir disoproxil fumarateA-S Medication SolutionsNDACurrent
53808-0208Atriplaefavirenz, emtricitabine, and tenofovir disoproxil fumarateDOH CENTRAL PHARMACYNDACurrent
70518-0341Atriplaefavirenz, emtricitabine, and tenofovir disoproxil fumarateREMEDYREPACK INC.NDACurrent
70518-0341Atriplaefavirenz, emtricitabine, and tenofovir disoproxil fumarateREMEDYREPACK INC.NDACurrent
70518-0341Atriplaefavirenz, emtricitabine, and tenofovir disoproxil fumarateREMEDYREPACK INC.NDACurrent
70518-0341Atriplaefavirenz, emtricitabine, and tenofovir disoproxil fumarateREMEDYREPACK INC.NDACurrent
70518-0341Atriplaefavirenz, emtricitabine, and tenofovir disoproxil fumarateREMEDYREPACK INC.NDACurrent
70518-0341Atriplaefavirenz, emtricitabine, and tenofovir disoproxil fumarateREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60722SUPPL2019-10-30
60720SUPPL2019-10-30
55036SUPPL2018-07-30
55031SUPPL2018-07-27
47979SUPPL2017-04-12
47916SUPPL2017-04-10
37916SUPPL2016-02-18
6498SUPPL2016-02-12
37915SUPPL2015-12-03
6497SUPPL2015-11-23
37914SUPPL2015-01-29
6496SUPPL2015-01-26
16606SUPPL2013-10-25
6495SUPPL2013-10-25
28884SUPPL2013-04-23
37913SUPPL2013-04-19
16605SUPPL2012-06-18
6494SUPPL2012-06-18
37912SUPPL2011-09-20
6493SUPPL2011-09-20
6492SUPPL2010-08-11
16604SUPPL2010-08-10
6491SUPPL2010-01-15
37911SUPPL2010-01-08
28883SUPPL2008-10-23
37910SUPPL2008-06-12
28882SUPPL2008-06-09
37909SUPPL2008-03-05
28881SUPPL2008-03-04
37908SUPPL2008-02-25
28880SUPPL2008-02-20
21875ORIG2006-12-13
28879ORIG2006-07-21
16603ORIG2006-07-12