FDA.reportPublic FDA data

Application 209385

Type
ANDA
Sponsor
NOSTRUM LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL325MG;5MGNoNo
002OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL325MG;7.5MGNoNo
003OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL325MG;10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
64850-621Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-621Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-621Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-621Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-621Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-622Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-622Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-622Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-622Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-622Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-623Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-623Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-623Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-623Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-623Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and AcetaminophenElite Laboratories, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76217ORIG 2023-11-03