Application 090217

Type
ANDA
Sponsor
SUN PHARM INDUSTRIES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDETABLET;ORALEQ 50MG BASENoNo
002MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDETABLET;ORALEQ 75MG BASENoNo
003MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDETABLET;ORALEQ 100MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57664-854MinocyclineMinocycline HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
57664-855MinocyclineMinocycline HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
57664-856MinocyclineMinocycline HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent