FDA.reportPublic FDA data

Application 077471

Type
ANDA
Sponsor
LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDETABLET;ORAL8MGNoNo
002HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDETABLET;ORAL2MGNoNo
003HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDETABLET;ORAL4MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0527-1353Hydromorphone HydrochlorideHydromorphone HydrochlorideLannett Company, Inc.ANDACurrent
0527-1353Hydromorphone HydrochlorideHydromorphone HydrochlorideLannett Company, Inc.ANDACurrent
0527-1353Hydromorphone HydrochlorideHydromorphone HydrochlorideLannett Company, Inc.ANDACurrent
0527-1354Hydromorphone HydrochlorideHydromorphone HydrochlorideLannett Company, Inc.ANDACurrent
0527-1354Hydromorphone HydrochlorideHydromorphone HydrochlorideLannett Company, Inc.ANDACurrent
0527-1354Hydromorphone HydrochlorideHydromorphone HydrochlorideLannett Company, Inc.ANDACurrent
0527-1355Hydromorphone HydrochlorideHydromorphone HydrochlorideLannett Company, Inc.ANDACurrent
0527-1355Hydromorphone HydrochlorideHydromorphone HydrochlorideLannett Company, Inc.ANDACurrent
0527-1355Hydromorphone HydrochlorideHydromorphone HydrochlorideLannett Company, Inc.ANDACurrent
35356-814Hydromorphone HydrochlorideHydromorphone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-814Hydromorphone HydrochlorideHydromorphone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-814Hydromorphone HydrochlorideHydromorphone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
52959-413Hydromorphone HydrochlorideHydromorphone HydrochlorideH.J. Harkins Company, Inc.ANDACurrent
63739-275Hydromorphone HydrochlorideHydromorphone HydrochlorideMcKesson CorporationANDACurrent
63739-791Hydromorphone HydrochlorideHydromorphone HydrochlorideMcKesson CorporationANDACurrent
67296-1642Hydromorphone HydrochlorideHydromorphone HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1642Hydromorphone HydrochlorideHydromorphone HydrochlorideRedPharm Drug, Inc.ANDACurrent
68084-423HYDROmorphone HydrochlorideHYDROmorphone HydrochlorideAmerican Health PackagingANDACurrent
68084-423HYDROmorphone HydrochlorideHYDROmorphone HydrochlorideAmerican Health PackagingANDACurrent
68084-423HYDROmorphone HydrochlorideHYDROmorphone HydrochlorideAmerican Health PackagingANDACurrent
68084-472HYDROmorphone HydrochlorideHYDROmorphone HydrochlorideAmerican Health PackagingANDACurrent
68084-472HYDROmorphone HydrochlorideHYDROmorphone HydrochlorideAmerican Health PackagingANDACurrent
68084-472HYDROmorphone HydrochlorideHYDROmorphone HydrochlorideAmerican Health PackagingANDACurrent
71335-0233Hydromorphone HydrochlorideHydromorphone HydrochlorideBryant Ranch PrepackANDACurrent
71335-0233Hydromorphone HydrochlorideHydromorphone HydrochlorideBryant Ranch PrepackANDACurrent
71335-0265Hydromorphone HydrochlorideHydromorphone HydrochlorideBryant Ranch PrepackANDACurrent
71335-0265Hydromorphone HydrochlorideHydromorphone HydrochlorideBryant Ranch PrepackANDACurrent
71335-0303Hydromorphone HydrochlorideHydromorphone HydrochlorideBryant Ranch PrepackANDACurrent
71335-0303Hydromorphone HydrochlorideHydromorphone HydrochlorideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76081ORIG 2023-11-02