FDA.reportPublic FDA data

Application 207419

Type
ANDA
Sponsor
ASCENT PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL325MG;2.5MGNoNo
002OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL325MG;5MGNoNo
003OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL325MG;7.5MGNoNo
004OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL325MG;10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
31722-191Oxycodone and AcetaminophenOxycodone and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-192Oxycodone and AcetaminophenOxycodone and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-193Oxycodone and AcetaminophenOxycodone and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-194Oxycodone and AcetaminophenOxycodone and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-948Oxycodone and AcetaminophenOxycodone and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-948Oxycodone and AcetaminophenOxycodone and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-948Oxycodone and AcetaminophenOxycodone and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-948Oxycodone and AcetaminophenOxycodone and AcetaminophenCamber Pharmaceuticals IncANDACurrent
31722-948Oxycodone and AcetaminophenOxycodone and AcetaminophenCamber Pharmaceuticals IncANDACurrent
31722-949Oxycodone and AcetaminophenOxycodone and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-949Oxycodone and AcetaminophenOxycodone and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-949Oxycodone and AcetaminophenOxycodone and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-949Oxycodone and AcetaminophenOxycodone and AcetaminophenCamber Pharmaceuticals IncANDACurrent
31722-949Oxycodone and AcetaminophenOxycodone and AcetaminophenCamber Pharmaceuticals IncANDACurrent
31722-950Oxycodone and AcetaminophenOxycodone and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-950Oxycodone and AcetaminophenOxycodone and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-950Oxycodone and AcetaminophenOxycodone and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-950Oxycodone and AcetaminophenOxycodone and AcetaminophenCamber Pharmaceuticals IncANDACurrent
31722-950Oxycodone and AcetaminophenOxycodone and AcetaminophenCamber Pharmaceuticals IncANDACurrent
31722-951Oxycodone and AcetaminophenOxycodone and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-951Oxycodone and AcetaminophenOxycodone and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-951Oxycodone and AcetaminophenOxycodone and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-951Oxycodone and AcetaminophenOxycodone and AcetaminophenCamber Pharmaceuticals IncANDACurrent
31722-951Oxycodone and AcetaminophenOxycodone and AcetaminophenCamber Pharmaceuticals IncANDACurrent
55700-967Oxycodone and AcetaminophenOxycodone and AcetaminophenQuality Care Products, LLCANDACurrent
55700-967Oxycodone and AcetaminophenOxycodone and AcetaminophenQuality Care Products, LLCANDACurrent
55700-967Oxycodone and AcetaminophenOxycodone and AcetaminophenQuality Care Products, LLCANDACurrent
55700-970Oxycodone and AcetaminophenOxycodone and AcetaminophenQuality Care Products, LLCANDACurrent
61919-835Oxycodone/APAPOxycodone/APAPDirect_RxANDACurrent
61919-835Oxycodone/APAPOxycodone/APAPDirect_RxANDACurrent
61919-871OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENDirect_RxANDACurrent
61919-871OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENDirect_RxANDACurrent
61919-871OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENDirect_RxANDACurrent
61919-871OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENDirect_RxANDACurrent
61919-871OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENDirect_RxANDACurrent
61919-871OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENDirect_RxANDACurrent
63629-1907Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
63629-1907Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
63629-1907Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
63629-1908Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
63629-1908Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
63629-1908Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
63629-1909Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
63629-1909Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
63629-1909Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
63629-1910Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
63629-1910Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
63629-1910Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
63629-1911Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
63629-1911Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
63629-1911Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
63629-1912Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
63629-1912Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
63629-1912Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
63629-7825Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
63629-8834Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
63629-8888Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
67296-1531Oxycodone and AcetaminophenOxycodone and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1531Oxycodone and AcetaminophenOxycodone and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1531Oxycodone and AcetaminophenOxycodone and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1815Oxycodone and AcetaminophenOxycodone and AcetaminophenRedPharm Drug,Inc.ANDACurrent
67296-1815Oxycodone and AcetaminophenOxycodone and AcetaminophenRedPharm Drug,Inc.ANDACurrent
67296-1815Oxycodone and AcetaminophenOxycodone and AcetaminophenRedPharm Drug,Inc.ANDACurrent
67296-1815Oxycodone and AcetaminophenOxycodone and AcetaminophenRedPharm Drug,Inc.ANDACurrent
68071-4839Oxycodone and AcetaminophenOxycodone and AcetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4839Oxycodone and AcetaminophenOxycodone and AcetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4852Oxycodone and AcetaminophenOxycodone and AcetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4852Oxycodone and AcetaminophenOxycodone and AcetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5054Oxycodone and AcetaminophenOxycodone and AcetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5054Oxycodone and AcetaminophenOxycodone and AcetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5054Oxycodone and AcetaminophenOxycodone and AcetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5054Oxycodone and AcetaminophenOxycodone and AcetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5169Oxycodone and AcetaminophenOxycodone and AcetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5169Oxycodone and AcetaminophenOxycodone and AcetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
71205-329Oxycodone and AcetaminophenOxycodone and AcetaminophenProficient Rx LPANDACurrent
71205-329Oxycodone and AcetaminophenOxycodone and AcetaminophenProficient Rx LPANDACurrent
71205-329Oxycodone and AcetaminophenOxycodone and AcetaminophenProficient Rx LPANDACurrent
71205-347Oxycodone and AcetaminophenOxycodone and AcetaminophenProficient Rx LPANDACurrent
71205-347Oxycodone and AcetaminophenOxycodone and AcetaminophenProficient Rx LPANDACurrent
71205-486Oxycodone and AcetaminophenOxycodone and AcetaminophenProficient Rx LPANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76532ORIG 2023-11-08