FDA.reportPublic FDA data

Application 091294

Type
ANDA
Sponsor
MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ABACAVIR SULFATEABACAVIR SULFATETABLET;ORALEQ 300MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-4105Abacavir Sulfateabacavir sulfateMylan Pharmaceuticals Inc.ANDACurrent
0378-4105Abacavir Sulfateabacavir sulfateMylan Pharmaceuticals Inc.ANDACurrent
51079-204Abacavir Sulfateabacavir sulfateMylan Institutional Inc.ANDACurrent
51079-204Abacavir Sulfateabacavir sulfateMylan Institutional Inc.ANDACurrent
51079-204Abacavir Sulfateabacavir sulfateMylan Institutional Inc.ANDACurrent
51079-204Abacavir Sulfateabacavir sulfateMylan Institutional Inc.ANDACurrent
53808-0627Abacavir Sulfateabacavir sulfateState of Florida DOH Central PharmacyANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62198ORIG2020-03-19
31523ORIG2012-06-20