FDA.reportPublic FDA data

Application 203068

Type
ANDA
Sponsor
AUROLIFE PHARMA LLC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13107-061Phentermine HydrochloridePhentermine HydrochlorideAurolife Pharma, LLCANDACurrent
45865-556Phentermine HydrochloridePhentermine Hydrochloridemedsource pharmaceuticalsANDACurrent
50090-4216Phentermine HydrochloridePhentermine HydrochlorideA-S Medication SolutionsANDACurrent
50090-4216Phentermine HydrochloridePhentermine HydrochlorideA-S Medication SolutionsANDACurrent
50090-4216Phentermine HydrochloridePhentermine HydrochlorideA-S Medication SolutionsANDACurrent
52959-812Phentermine HydrochloridePhentermine HydrochlorideH.J. Harkins Company, Inc.ANDACurrent
63187-800Phentermine HydrochloridePhentermine HydrochlorideProficient Rx LPANDACurrent
63187-800Phentermine HydrochloridePhentermine HydrochlorideProficient Rx LPANDACurrent
63187-800Phentermine HydrochloridePhentermine HydrochlorideProficient Rx LPANDACurrent
63187-800Phentermine HydrochloridePhentermine HydrochlorideProficient Rx LPANDACurrent
63187-800Phentermine HydrochloridePhentermine HydrochlorideProficient Rx LPANDACurrent
70518-2278Phentermine HydrochloridePhentermine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2278Phentermine HydrochloridePhentermine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2278Phentermine HydrochloridePhentermine HydrochlorideREMEDYREPACK INC.ANDACurrent
72189-203PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDEDIRECT RXANDACurrent