FDA.reportPublic FDA data

Application 087190

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDECAPSULE;ORAL30MGNoYes
002PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDECAPSULE;ORAL15MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0185-0644phentermine hydrochloridephentermine hydrochlorideEon Labs, Inc.ANDACurrent
0185-0647phentermine hydrochloridephentermine hydrochlorideEon Labs, Inc.ANDACurrent
50436-9028phentermine hydrochloridephentermine hydrochlorideUnit Dose ServicesANDACurrent