FDA.reportPublic FDA data

Application 089450

Type
ANDA
Sponsor
ANDA REPOSITORY

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
46672-561acetaminophen and codeine phosphateacetaminophen and codeine phosphateMikart, LLCANDACurrent
46672-561acetaminophen and codeine phosphateacetaminophen and codeine phosphateMikart, Inc.ANDACurrent
46672-561acetaminophen and codeine phosphateacetaminophen and codeine phosphateMikart, Inc.ANDACurrent
46672-561acetaminophen and codeine phosphateacetaminophen and codeine phosphateMikart, LLCANDACurrent
46672-561acetaminophen and codeine phosphateacetaminophen and codeine phosphateMikart, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76115ORIG 2023-11-02