FDA.reportPublic FDA data

Application 020666

Type
NDA
Sponsor
IMPAX LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALBENZAALBENDAZOLETABLET;ORAL200MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-1701AlbendazolealbendazoleAmneal Pharmaceuticals of New York LLCNDACurrent
0115-1701AlbendazolealbendazoleAmneal Pharmaceuticals of New York LLCNDACurrent
0115-1701AlbendazolealbendazoleAmneal Pharmaceuticals of New York LLCNDACurrent
0115-1701AlbendazolealbendazoleAmneal Pharmaceuticals of New York LLCNDACurrent
0115-1701AlbendazolealbendazoleAmneal Pharmaceuticals of New York LLCNDACurrent
0115-1701AlbendazolealbendazoleImpax GenericsNDACurrent
52054-550ALBENZAalbendazoleAmedra Pharmaceuticals LLCNDACurrent
54505-055AlbendazoleAlbendazoleLineage Therapeutics IncNDACurrent
54505-055AlbendazoleAlbendazoleLineage Therapeutics IncNDACurrent
54505-055AlbendazoleAlbendazoleLineage Therapeutics IncNDACurrent
55695-021ALBENZAalbendazoleDepartment of State Health Services, Pharmacy BranchNDACurrent
64896-693ALBENZAalbendazoleAmneal Pharmaceuticals LLCNDACurrent
64896-693ALBENZAalbendazoleAmneal Pharmaceuticals LLCNDACurrent
64896-693ALBENZAalbendazoleAmneal Pharmaceuticals LLCNDACurrent
64896-693ALBENZAalbendazoleAmneal Pharmaceuticals LLCNDACurrent
64896-693ALBENZAalbendazoleImpax Specialty PharmaNDACurrent
64896-693ALBENZAalbendazoleAmneal Pharmaceuticals LLCNDACurrent
65084-462ALBENZAalbendazoleMckesson Rxpak IncNDACurrent
76413-145ALBENZAalbendazoleCentral Texas Community Health CentersNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59323SUPPL2019-07-12
59318SUPPL2019-07-12
57684ORIG2019-02-15
57046SUPPL2018-12-28
56218SUPPL2018-10-31
50888SUPPL2017-12-27
50846SUPPL2017-12-22
12952SUPPL2015-06-12
3037SUPPL2015-06-12
25472SUPPL2009-11-19
3036SUPPL2009-11-19
35111SUPPL2009-10-21
35110SUPPL2009-10-21
3035SUPPL2007-08-22
35109SUPPL2007-08-21