FDA.reportPublic FDA data

Application 078439

Type
ANDA
Sponsor
LANNETT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDETABLET;ORAL2MGNoNo
002HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDETABLET;ORAL4MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
35356-815Hydromorphone HydrochlorideHydromorphone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-815Hydromorphone HydrochlorideHydromorphone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-815Hydromorphone HydrochlorideHydromorphone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-815Hydromorphone HydrochlorideHydromorphone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-816Hydromorphone HydrochlorideHydromorphone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-816Hydromorphone HydrochlorideHydromorphone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-816Hydromorphone HydrochlorideHydromorphone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-816Hydromorphone HydrochlorideHydromorphone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
52959-408Hydromorphone HydrochlorideHydromorphone HydrochlorideH.J. Harkins Company, Inc.ANDACurrent
52959-420Hydromorphone HydrochlorideHydromorphone HydrochlorideH.J. Harkins Company, Inc.ANDACurrent
68084-423Hydromorphone HydrochlorideHydromorphone HydrochlorideAmerican Health PackagingANDACurrent
68084-472Hydromorphone HydrochlorideHydromorphone HydrochlorideAmerican Health PackagingANDACurrent