FDA.reportPublic FDA data

Application 075201

Type
ANDA
Sponsor
ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INDAPAMIDEINDAPAMIDETABLET;ORAL1.25MGNoNo
002INDAPAMIDEINDAPAMIDETABLET;ORAL2.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43975-217INDAPAMIDEINDAPAMIDEAmerigen Pharmaceuticals Inc.ANDACurrent
43975-217INDAPAMIDEINDAPAMIDEANI Pharmaceuticals, Inc.ANDACurrent
43975-217INDAPAMIDEINDAPAMIDEANI Pharmaceuticals, Inc.ANDACurrent
43975-217INDAPAMIDEINDAPAMIDEAmerigen Pharmaceuticals Inc.ANDACurrent
43975-217INDAPAMIDEINDAPAMIDEANI Pharmaceuticals, Inc.ANDACurrent
43975-304INDAPAMIDEINDAPAMIDEAmerigen Pharmaceuticals Inc.ANDACurrent
43975-304INDAPAMIDEINDAPAMIDEANI Pharmaceuticals, Inc.ANDACurrent
43975-304INDAPAMIDEINDAPAMIDEANI Pharmaceuticals, Inc.ANDACurrent
43975-304INDAPAMIDEINDAPAMIDEAmerigen Pharmaceuticals Inc.ANDACurrent
43975-304INDAPAMIDEINDAPAMIDEANI Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8561ORIG1998-12-04