FDA.reportPublic FDA data

Application 087006

Type
ANDA
Sponsor
WOCKHARDT BIO AG

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATESOLUTION;ORAL120MG/5ML;12MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60432-245Acetaminophen and Codeine Phosphateacetaminophen and codeine phosphateMorton Grove Pharmaceuticals, Inc.ANDACurrent
60432-245Acetaminophen and Codeine Phosphateacetaminophen and codeine phosphateMorton Grove Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76212ORIG 2023-11-03
53920ORIG2018-05-01