FDA.reportPublic FDA data

Application 212418

Type
ANDA
Sponsor
ELITE LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATETABLET;ORAL300MG;15MGNoNo
002ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATETABLET;ORAL300MG;30MGNoNo
003ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATETABLET;ORAL300MG;60MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
64850-641Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateElite Laboratories, Inc.ANDACurrent
64850-641Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateElite Laboratories, Inc.ANDACurrent
64850-641Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateElite Laboratories, Inc.ANDACurrent
64850-642Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateElite Laboratories, Inc.ANDACurrent
64850-642Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateElite Laboratories, Inc.ANDACurrent
64850-642Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateElite Laboratories, Inc.ANDACurrent
64850-643Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateElite Laboratories, Inc.ANDACurrent
64850-643Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateElite Laboratories, Inc.ANDACurrent
64850-643Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateElite Laboratories, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76448ORIG 2023-11-07