Application 203232

Type
ANDA
Sponsor
MACLEODS PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATETABLET;ORAL300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6821tenofovir disproxil fumaratetenofovir disproxil fumarateMajor PharmaceuticalsANDACurrent
33342-096tenofovir disproxil fumaratetenofovir disproxil fumarateMacleods Pharmaceuticals LimitedANDACurrent
33342-096tenofovir disproxil fumaratetenofovir disproxil fumarateMacleods Pharmaceuticals LimitedANDACurrent
33342-096tenofovir disproxil fumaratetenofovir disproxil fumarateMacleods Pharmaceuticals LimitedANDACurrent
33342-096tenofovir disproxil fumaratetenofovir disproxil fumarateMacleods Pharmaceuticals LimitedANDACurrent
33342-096tenofovir disproxil fumaratetenofovir disproxil fumarateMacleods Pharmaceuticals LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32401ORIG2014-08-07