FDA.reportPublic FDA data

Application 040545

Type
ANDA
Sponsor
SPECGX LLC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0406-0522OXYCODONE AND ACETAMINOPHENoxycodone hydrochloride and acetaminophenSpecGx LLCANDACurrent
0406-0522OXYCODONE AND ACETAMINOPHENoxycodone hydrochloride and acetaminophenSpecGx LLCANDACurrent
0406-0522OXYCODONE AND ACETAMINOPHENoxycodone hydrochloride and acetaminophenSpecGx LLCANDACurrent
0406-0522OXYCODONE AND ACETAMINOPHENoxycodone hydrochloride and acetaminophenSpecGx LLCANDACurrent
0406-0523OXYCODONE AND ACETAMINOPHENoxycodone hydrochloride and acetaminophenSpecGx LLCANDACurrent
0406-0523OXYCODONE AND ACETAMINOPHENoxycodone hydrochloride and acetaminophenSpecGx LLCANDACurrent
0406-0523OXYCODONE AND ACETAMINOPHENoxycodone hydrochloride and acetaminophenSpecGx LLCANDACurrent
0406-0523OXYCODONE AND ACETAMINOPHENoxycodone hydrochloride and acetaminophenSpecGx LLCANDACurrent
21695-233OXYCODONE AND ACETAMINOPHENoxycodone hydrochloride and acetaminophenRebel Distributors CorpANDACurrent
55700-983OXYCODONE AND ACETAMINOPHENoxycodone hydrochloride and acetaminophenQuality Care Products, LLCANDACurrent
55700-984OXYCODONE AND ACETAMINOPHENoxycodone hydrochloride and acetaminophenQuality Care Products, LLCANDACurrent
66336-147OXYCODONE AND ACETAMINOPHENoxycodone hydrochloride and acetaminophenDispensing Solutions, Inc.ANDACurrent
70518-3492OXYCODONE AND ACETAMINOPHENoxycodone hydrochloride and acetaminophenREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76182ORIG 2023-11-03