FDA.reportPublic FDA data

Application 209921

Type
ANDA
Sponsor
ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PENICILLAMINEPENICILLAMINECAPSULE;ORAL250MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43975-309PenicillaminePenicillamineANI Pharmaceuticals, Inc.ANDACurrent
43975-309PenicillaminePenicillamineANI Pharmaceuticals, Inc.ANDACurrent
43975-309PenicillaminePenicillamineANI Pharmaceuticals, Inc.ANDACurrent
43975-309PenicillaminePenicillamineAmerigen Pharmaceuticals, Inc.ANDACurrent
62559-970PenicillaminePenicillamineANI Pharmaceuticals, Inc.ANDACurrent
62559-970PenicillaminePenicillamineANI Pharmaceuticals, Inc.ANDACurrent
62559-970PenicillaminePenicillamineANI Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59088ORIG2019-06-17