FDA.reportPublic FDA data

Application 040860

Type
ANDA
Sponsor
INGENUS PHARMS NJ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATEASPIRIN; CARISOPRODOL; CODEINE PHOSPHATETABLET;ORAL325MG;200MG;16MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50742-256CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATEcarisoprodol, aspirin and codeine phosphateIngenus Pharmaceuticals, LLCANDACurrent
50742-256CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATEcarisoprodol, aspirin and codeine phosphateIngenus Pharmaceuticals, LLCANDACurrent
50742-256Carisoprodol, Aspirin and Codeine PhosphateCarisoprodol, Aspirin and Codeine PhosphateIngenus Pharmaceuticals, LLCANDACurrent
50742-256Carisoprodol, Aspirin and Codeine PhosphateCarisoprodol, Aspirin and Codeine PhosphateIngenus Pharmaceuticals, LLCANDACurrent
64980-176Carisoprodol, Aspirin and Codeine PhosphateCarisoprodol, Aspirin and Codeine PhosphateRising Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76075ORIG 2023-11-02