FDA.reportPublic FDA data

Application 040105

Type
ANDA
Sponsor
VINTAGE PHARMS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0603-4998Oxycodone and AcetaminophenOxycodone hydrochloride and AcetaminophenPar PharmaceuticalANDACurrent
0603-4998Oxycodone and AcetaminophenOxycodone hydrochloride and AcetaminophenPar PharmaceuticalANDACurrent
0603-4998Oxycodone and AcetaminophenOxycodone hydrochloride and AcetaminophenPar PharmaceuticalANDACurrent
0904-6437Oxycodone and AcetaminophenOxycodone hydrochloride and AcetaminophenMajor PharmaceuticalsANDACurrent
0904-6437Oxycodone and AcetaminophenOxycodone hydrochloride and AcetaminophenMajor PharmaceuticalsANDACurrent
21695-616Oxycodone and AcetaminophenOxycodone hydrochloride and AcetaminophenRebel Distributors CorpANDACurrent
52959-556Oxycodone and AcetaminophenOxycodone hydrochloride and AcetaminophenH.J. Harkins Company, Inc.ANDACurrent
61919-248OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENDirectRXANDACurrent
63187-406Oxycodone and AcetaminophenOxycodone hydrochloride and AcetaminophenProficient Rx LPANDACurrent
63187-406Oxycodone and AcetaminophenOxycodone hydrochloride and AcetaminophenProficient Rx LPANDACurrent
67296-1301Oxycodone and AcetaminophenOxycodone and AcetaminophenRedPharm Drug, Inc,ANDACurrent
67296-1301Oxycodone and AcetaminophenOxycodone and AcetaminophenRedPharm Drug, Inc,ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76158ORIG 2023-11-03
22084ORIG2003-12-23