FDA.reportPublic FDA data

Application 087463

Type
ANDA
Sponsor
SPECGX LLC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0406-0512OXYCODONE AND ACETAMINOPHENoxycodone hydrochloride and acetaminophenSpecGx LLCANDACurrent
0406-0512OXYCODONE AND ACETAMINOPHENoxycodone hydrochloride and acetaminophenSpecGx LLCANDACurrent
0406-0512OXYCODONE AND ACETAMINOPHENoxycodone hydrochloride and acetaminophenSpecGx LLCANDACurrent
0406-0512OXYCODONE AND ACETAMINOPHENoxycodone hydrochloride and acetaminophenSpecGx LLCANDACurrent
10544-287OXYCODONE AND ACETAMINOPHENoxycodone hydrochloride and acetaminophenBlenheim Pharmacal, Inc.ANDACurrent
49999-852Oxycodone and AcetaminophenOxycodone and AcetaminophenQuality Care products LLCANDACurrent
49999-852Oxycodone and AcetaminophenOxycodone and AcetaminophenQuality Care products LLCANDACurrent
67296-0355OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENRedPharm Drug, Inc.ANDACurrent
67296-0355OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENRedPharm Drug, Inc.ANDACurrent
67296-0355OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENRedPharm Drug, Inc.ANDACurrent