FDA.reportPublic FDA data

Application 076723

Type
ANDA
Sponsor
NOSTRUM LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDETABLET;ORAL8MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51224-102Hydromorphone HydrochlorideHydromorphone HydrochlorideTAGI Pharma, Inc.ANDACurrent
51224-102Hydromorphone HydrochlorideHydromorphone HydrochlorideTAGI Pharma, Inc.ANDACurrent
64850-402Hydromorphone HydrochlorideHydromorphone HydrochlorideElite Laboratories, Inc.ANDACurrent
68094-852Hyrdomorphone HydrochlorideHydromorphone HydrochloridePrecision Dose Inc.ANDACurrent
70399-102DILAUDIDHydromorphone HydrochlorideV1 Pharma LlcANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76309ORIG 2023-11-03
44319ORIG2005-10-27