FDA.reportPublic FDA data

Application 207510

Type
ANDA
Sponsor
WES PHARMA 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
0904-7093OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenMajor PharmaceuticalsANDACurrent
0904-7093OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenMajor PharmaceuticalsANDACurrent
0904-7094OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenMajor PharmaceuticalsANDACurrent
0904-7094OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenMajor PharmaceuticalsANDACurrent
0904-7095OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenMajor PharmaceuticalsANDACurrent
0904-7095OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenMajor PharmaceuticalsANDACurrent
43598-546oxycodone and acetaminophenoxycodone and acetaminophenDr. ReddyANDACurrent
43598-546oxycodone and acetaminophenoxycodone and acetaminophenDr. ReddyANDACurrent
43598-546oxycodone and acetaminophenoxycodone and acetaminophenDr. ReddyANDACurrent
43598-547oxycodone and acetaminophenoxycodone and acetaminophenDr. ReddyANDACurrent
43598-547oxycodone and acetaminophenoxycodone and acetaminophenDr. ReddyANDACurrent
43598-547oxycodone and acetaminophenoxycodone and acetaminophenDr. ReddyANDACurrent
60687-642OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenAmerican Health PackagingANDACurrent
60687-642Oxycodone and AcetaminophenOxycodone and AcetaminophenAmerican Health PackagingANDACurrent
63629-1942OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenBryant Ranch PrepackANDACurrent
63629-1942OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenBryant Ranch PrepackANDACurrent
63629-1943OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenBryant Ranch PrepackANDACurrent
63629-1943OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenBryant Ranch PrepackANDACurrent
68071-2598OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2856OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
71335-2049OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenBryant Ranch PrepackANDACurrent
71930-045OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenEywa Pharma IncANDACurrent
71930-045OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenEywa Pharma IncANDACurrent
71930-045OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenEywa Pharma IncANDACurrent
71930-045OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenEywa Pharma IncANDACurrent
71930-046OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenEywa Pharma IncANDACurrent
71930-046OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenEywa Pharma IncANDACurrent
71930-046OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenEywa Pharma IncANDACurrent
71930-046OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenEywa Pharma IncANDACurrent
71930-047OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenEywa Pharma IncANDACurrent
71930-047OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenEywa Pharma IncANDACurrent
71930-047OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenEywa Pharma IncANDACurrent
71930-047OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenEywa Pharma IncANDACurrent
72189-255OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENDIRECT RXANDACurrent
72189-255OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENDIRECT RXANDACurrent
72189-256OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENDIRECT RXANDACurrent
72189-256OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENDIRECT RXANDACurrent
72189-257OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENDirectRxANDACurrent
72189-257OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENDirectRxANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76201ORIG 2023-11-03