Application 089828

Type
ANDA
Sponsor
VINTAGE PHARMS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0440-7027Acetaminophen And Codeineacetaminophen and codeine phosphateLiberty Pharmaceuticals, Inc.ANDACurrent
0603-2339Acetaminophen And Codeineacetaminophen and codeine phosphatePar PharmaceuticalANDACurrent
0603-2339Acetaminophen And Codeineacetaminophen and codeine phosphatePar PharmaceuticalANDACurrent
0603-2339Acetaminophen And Codeineacetaminophen and codeine phosphatePar Pharmaceutical, Inc.ANDACurrent
33261-002Acetaminophen And Codeineacetaminophen and codeine phosphateAidarex Pharmaceuticals LLCANDACurrent
33358-002Acetaminophen And Codeineacetaminophen and codeine phosphateRxChange Co.ANDACurrent
61919-472ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINEDIRECT RXANDACurrent
67544-474Acetaminophen And Codeineacetaminophen and codeine phosphateAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-474Acetaminophen And Codeineacetaminophen and codeine phosphateAphena Pharma Solutions - Tennessee, LLCANDACurrent
68084-373Acetaminophen And Codeine Phosphateacetaminophen and codeine phosphateAmerican Health PackagingANDACurrent
68084-373Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAmerican Health PackagingANDACurrent
68084-373Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAmerican Health PackagingANDACurrent
68084-373Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAmerican Health PackagingANDACurrent
68788-9259Acetaminophen And Codeineacetaminophen and codeine phosphatePreferred Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76155ORIG 2023-11-03