FDA.reportPublic FDA data

Application 204278

Type
ANDA
Sponsor
PADDOCK LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL8MGNoNo
002HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL12MGNoNo
003HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL16MGNoNo
004HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL32MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0574-0293hydromorphone hydrochloridehydromorphone hydrochloridePadagis US LLCANDACurrent
0574-0293hydromorphone hydrochloridehydromorphone hydrochloridePaddock Laboratories, LLCANDACurrent
0574-0293hydromorphone hydrochloridehydromorphone hydrochloridePaddock Laboratories, LLC.ANDACurrent
0574-0293hydromorphone hydrochloridehydromorphone hydrochloridePaddock Laboratories, LLC.ANDACurrent
0574-0293hydromorphone hydrochloridehydromorphone hydrochloridePaddock Laboratories, LLCANDACurrent
0574-0293hydromorphone hydrochloridehydromorphone hydrochloridePadagis US LLCANDACurrent
0574-0294hydromorphone hydrochloridehydromorphone hydrochloridePadagis US LLCANDACurrent
0574-0294hydromorphone hydrochloridehydromorphone hydrochloridePadagis US LLCANDACurrent
0574-0294hydromorphone hydrochloridehydromorphone hydrochloridePaddock Laboratories, LLCANDACurrent
0574-0294hydromorphone hydrochloridehydromorphone hydrochloridePaddock Laboratories, LLC.ANDACurrent
0574-0294hydromorphone hydrochloridehydromorphone hydrochloridePaddock Laboratories, LLC.ANDACurrent
0574-0294hydromorphone hydrochloridehydromorphone hydrochloridePaddock Laboratories, LLCANDACurrent
0574-0295hydromorphone hydrochloridehydromorphone hydrochloridePadagis US LLCANDACurrent
0574-0295hydromorphone hydrochloridehydromorphone hydrochloridePaddock Laboratories, LLCANDACurrent
0574-0295hydromorphone hydrochloridehydromorphone hydrochloridePaddock Laboratories, LLC.ANDACurrent
0574-0295hydromorphone hydrochloridehydromorphone hydrochloridePaddock Laboratories, LLC.ANDACurrent
0574-0295hydromorphone hydrochloridehydromorphone hydrochloridePaddock Laboratories, LLCANDACurrent
0574-0295hydromorphone hydrochloridehydromorphone hydrochloridePadagis US LLCANDACurrent
0574-0297hydromorphone hydrochloridehydromorphone hydrochloridePadagis US LLCANDACurrent
0574-0297hydromorphone hydrochloridehydromorphone hydrochloridePadagis US LLCANDACurrent
0574-0297hydromorphone hydrochloridehydromorphone hydrochloridePaddock Laboratories, LLCANDACurrent
0574-0297hydromorphone hydrochloridehydromorphone hydrochloridePaddock Laboratories, LLC.ANDACurrent
0574-0297hydromorphone hydrochloridehydromorphone hydrochloridePaddock Laboratories, LLC.ANDACurrent
0574-0297hydromorphone hydrochloridehydromorphone hydrochloridePaddock Laboratories, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44592ORIG2015-06-30
43973ORIG2015-04-14
10316ORIG2015-04-08