FDA.reportPublic FDA data

Application 212133

Type
ANDA
Sponsor
ASCENT PHARMS INC

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
31722-119hydromorphone hydrochloridehydromorphone hydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
31722-120hydromorphone hydrochloridehydromorphone hydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
31722-121hydromorphone hydrochloridehydromorphone hydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
31722-122hydromorphone hydrochloridehydromorphone hydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
43602-266hydromorphone hydrochloridehydromorphone hydrochlorideAscent Pharmaceuticals, Inc.ANDACurrent
43602-267hydromorphone hydrochloridehydromorphone hydrochlorideAscent Pharmaceuticals, Inc.ANDACurrent
43602-268hydromorphone hydrochloridehydromorphone hydrochlorideAscent Pharmaceuticals, Inc.ANDACurrent
43602-269hydromorphone hydrochloridehydromorphone hydrochlorideAscent Pharmaceuticals, Inc.ANDACurrent
72865-168hydromorphone hydrochloridehydromorphone hydrochlorideXLCare Pharmaceuticals, Inc.ANDACurrent
72865-169hydromorphone hydrochloridehydromorphone hydrochlorideXLCare Pharmaceuticals, Inc.ANDACurrent
72865-170hydromorphone hydrochloridehydromorphone hydrochlorideXLCare Pharmaceuticals, Inc.ANDACurrent
72865-171hydromorphone hydrochloridehydromorphone hydrochlorideXLCare Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76466ORIG 2023-11-07