FDA.report

Application 089805

Type
ANDA
Sponsor
VINTAGE

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATETABLET;ORAL300MG;30MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0440-7026Acetaminophen And Codeineacetaminophen and codeine phosphateLiberty Pharmaceuticals, Inc.ANDACurrent
0603-2338Acetaminophen And Codeineacetaminophen and codeine phosphatePar PharmaceuticalANDACurrent
0603-2338Acetaminophen And Codeineacetaminophen and codeine phosphatePar PharmaceuticalANDACurrent
0603-2338Acetaminophen And Codeineacetaminophen and codeine phosphatePar Pharmaceutical, Inc.ANDACurrent
10544-100Acetaminophen and Codeineacetaminophen and codeine phosphateBlenheim Pharmacal, Inc.ANDACurrent
12634-526ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEApotheca, Inc.ANDACurrent
33261-001Acetaminophen And Codeineacetaminophen and codeine phosphateAidarex Pharmaceuticals LLCANDACurrent
52959-003Acetaminophen And Codeineacetaminophen and codeine phosphateH.J. Harkins Company, Inc.ANDACurrent
54348-015ACETAMINOPHEN with CODEINEACETAMINOPHEN, CODEINE PHOSPHATEPharmPak, Inc.ANDACurrent
63187-470Acetaminophen And Codeineacetaminophen and codeine phosphateProficient Rx LPANDACurrent
63187-470Acetaminophen And Codeineacetaminophen and codeine phosphateProficient Rx LPANDACurrent
66336-059Acetaminophen And Codeineacetaminophen and codeine phosphateDispensing Solutions, Inc.ANDACurrent
67046-902Acetaminophen And Codeineacetaminophen and codeine phosphateContract Pharmacy Services-PAANDACurrent
67296-0544Acetaminophen And Codeineacetaminophen and codeine phosphateRedPharm Drug Inc.ANDACurrent
67544-882Acetaminophen And Codeineacetaminophen and codeine phosphateAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-882Acetaminophen And Codeineacetaminophen and codeine phosphateAphena Pharma Solutions - Tennessee, LLCANDACurrent
68084-372Acetaminophen And Codeine Phosphateacetaminophen and codeine phosphateAmerican Health PackagingANDACurrent
68084-372Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAmerican Health PackagingANDACurrent
68084-372Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAmerican Health PackagingANDACurrent
68084-372Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAmerican Health PackagingANDACurrent
68387-250Acetaminophen And Codeineacetaminophen and codeine phosphateKeltman Pharmaceuticals Inc.ANDACurrent

Documents

DocumentSubmission typeDate
76150ORIG 2023-11-03