FDA.reportPublic FDA data

Application 040527

Type
ANDA
Sponsor
SUN PHARM INDUSTRIES

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
10544-602Phentermine HydrochloridePhentermine HydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
21695-513Phentermine HydrochloridePhentermine HydrochlorideRebel Distributors Corp.ANDACurrent
52959-812Phentermine HydrochloridePhentermine HydrochlorideH.J. Harkins Company, Inc.ANDACurrent
66336-344Phentermine HydrochloridePhentermine HydrochlorideDispensing Solutions, Inc.ANDACurrent
68387-690Phentermine HydrochloridePhentermine HydrochlorideKeltman Pharmaceuticals Inc.ANDACurrent