FDA.reportPublic FDA data

Application 205017

Type
ANDA
Sponsor
NUVO PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDECAPSULE;ORAL37.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11534-159Phentermine hydrochloridephentermine hydrochlorideSUNRISE PHARMACEUTICAL, INC.ANDACurrent
11534-159Phentermine hydrochloridephentermine hydrochlorideSUNRISE PHARMACEUTICAL, INC.ANDACurrent
11534-159Phentermine hydrochloridephentermine hydrochlorideSUNRISE PHARMACEUTICAL, INC.ANDACurrent
63629-2386Phentermine hydrochloridephentermine hydrochlorideBryant Ranch PrepackANDACurrent
63629-2386Phentermine hydrochloridephentermine hydrochlorideBryant Ranch PrepackANDACurrent
63629-2387Phentermine hydrochloridephentermine hydrochlorideBryant Ranch PrepackANDACurrent
63629-2387Phentermine hydrochloridephentermine hydrochlorideBryant Ranch PrepackANDACurrent
71335-0646Phentermine hydrochloridephentermine hydrochlorideBryant Ranch PrepackANDACurrent
71335-0646Phentermine hydrochloridephentermine hydrochlorideBryant Ranch PrepackANDACurrent
71335-0646Phentermine hydrochloridephentermine hydrochlorideBryant Ranch PrepackANDACurrent