FDA.reportPublic FDA data

Application 040282

Type
ANDA
Sponsor
MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIGOXINDIGOXINTABLET;ORAL0.125MGNoNo
002DIGOXINDIGOXINTABLET;ORAL0.25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-6155DIGITEKdigoxinMylan Pharmaceuticals Inc.ANDACurrent
0378-6155DIGITEKdigoxinMylan Pharmaceuticals Inc.ANDACurrent
0378-6156DIGITEKdigoxinMylan Pharmaceuticals Inc.ANDACurrent
0378-6156DIGITEKdigoxinMylan Pharmaceuticals Inc.ANDACurrent
42292-002DIGITEKdigoxinMylan Institutional Inc.ANDACurrent
42292-002DIGITEKdigoxinMylan Institutional Inc.ANDACurrent
42292-002DIGITEKdigoxinMylan Institutional Inc.ANDACurrent
42292-002DIGITEKdigoxinMylan Institutional Inc.ANDACurrent
42292-002DIGITEKdigoxinMylan Institutional Inc.ANDACurrent
42292-003DIGITEKdigoxinMylan Institutional Inc.ANDACurrent
42292-003DIGITEKdigoxinMylan Institutional Inc.ANDACurrent
42292-003DIGITEKdigoxinMylan Institutional Inc.ANDACurrent
42292-003DIGITEKdigoxinMylan Institutional Inc.ANDACurrent
42292-003DIGITEKdigoxinMylan Institutional Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
7603SUPPL2014-09-04
29912ORIG1999-12-23
22116ORIG1999-12-23