FDA.reportPublic FDA data

Application 203133

Type
ANDA
Sponsor
AMNEAL PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXTROMETHORPHAN POLISTIREXDEXTROMETHORPHAN POLISTIREXSUSPENSION, EXTENDED RELEASE;ORALEQ 30MG HYDROBROMIDE/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65162-700Dextromethorphan Polistirex Extended-ReleaseDextromethorphan PolistirexAmneal Pharmaceuticals LLCANDACurrent
65162-700Dextromethorphan Polistirex Extended-ReleaseDextromethorphan PolistirexAmneal Pharmaceuticals LLCANDACurrent
65162-700Dextromethorphan Polistirex Extended-ReleaseDextromethorphan PolistirexAmneal Pharmaceuticals LLCANDACurrent
65162-700Dextromethorphan Polistirex Extended-ReleaseDextromethorphan PolistirexAmneal Pharmaceuticals LLCANDACurrent
65162-799Dextromethorphan Polistirex Extended-ReleaseDextromethorphan PolistirexAmneal Pharmaceuticals LLCANDACurrent
65162-799Dextromethorphan Polistirex Extended-ReleaseDextromethorphan PolistirexAmneal Pharmaceuticals LLCANDACurrent
65162-799Dextromethorphan Polistirex Extended-ReleaseDextromethorphan PolistirexAmneal Pharmaceuticals LLCANDACurrent
65162-799Dextromethorphan Polistirex Extended-ReleaseDextromethorphan PolistirexAmneal Pharmaceuticals LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68762ORIG2021-09-24