FDA.reportPublic FDA data

Application 211228

Type
ANDA
Sponsor
ASCENT PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDETABLET;ORAL5MGNoNo
002METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
31722-946Methadone HydrochlorideMethadone HydrochlorideCamber Pharmaceuticals, IncANDACurrent
31722-946Methadone HydrochlorideMethadone HydrochlorideCamber Pharmaceuticals, IncANDACurrent
31722-946Methadone HydrochlorideMethadone HydrochlorideCamber Pharmaceuticals, IncANDACurrent
31722-946Methadone HydrochlorideMethadone HydrochlorideCamber Pharmaceuticals, IncANDACurrent
31722-947Methadone HydrochlorideMethadone HydrochlorideCamber Pharmaceuticals, IncANDACurrent
31722-947Methadone HydrochlorideMethadone HydrochlorideCamber Pharmaceuticals, IncANDACurrent
31722-947Methadone HydrochlorideMethadone HydrochlorideCamber Pharmaceuticals, IncANDACurrent
31722-947Methadone HydrochlorideMethadone HydrochlorideCamber Pharmaceuticals, IncANDACurrent
63629-1905Methadone HydrochlorideMethadone HydrochlorideBryant Ranch PrepackANDACurrent
63629-1905Methadone HydrochlorideMethadone HydrochlorideBryant Ranch PrepackANDACurrent
63629-1905Methadone HydrochlorideMethadone HydrochlorideBryant Ranch PrepackANDACurrent
63629-1906Methadone HydrochlorideMethadone HydrochlorideBryant Ranch PrepackANDACurrent
63629-1906Methadone HydrochlorideMethadone HydrochlorideBryant Ranch PrepackANDACurrent
63629-1906Methadone HydrochlorideMethadone HydrochlorideBryant Ranch PrepackANDACurrent
72865-120Methadone HydrochlorideMethadone HydrochlorideXLCare Pharmaceuticals, IncANDACurrent
72865-121Methadone HydrochlorideMethadone HydrochlorideXLCare Pharmaceuticals, IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76434ORIG 2023-11-07