FDA.reportPublic FDA data

Application 202677

Type
ANDA
Sponsor
ALVOGEN

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
33261-196Oxycodone and AcetaminophenOxycodone and AcetaminophenAidarex Pharmaceuticals LLCANDACurrent
35356-801Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Product s LLCANDACurrent
35356-801Oxycodone and AcetaminophenOxycodone and AcetaminophenQuality Care Products, LLCANDACurrent
35356-802Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Product s LLCANDACurrent
47781-196Oxycodone and AcetaminophenOxycodone and AcetaminophenAlvogen, Inc.ANDACurrent
47781-196Oxycodone and AcetaminophenOxycodone and AcetaminophenAlvogen, Inc.ANDACurrent
47781-196Oxycodone and AcetaminophenOxycodone and AcetaminophenAlvogen, Inc.ANDACurrent
47781-196Oxycodone and AcetaminophenOxycodone and AcetaminophenAlvogen, Inc.ANDACurrent
47781-196Oxycodone and AcetaminophenOxycodone and AcetaminophenAlvogen, Inc.ANDACurrent
47781-229Oxycodone and AcetaminophenOxycodone and AcetaminophenAlvogen, Inc.ANDACurrent
47781-229Oxycodone and AcetaminophenOxycodone and AcetaminophenAlvogen, Inc.ANDACurrent
47781-229Oxycodone and AcetaminophenOxycodone and AcetaminophenAlvogen, Inc.ANDACurrent
47781-229Oxycodone and AcetaminophenOxycodone and AcetaminophenAlvogen, Inc.ANDACurrent
47781-229Oxycodone and AcetaminophenOxycodone and AcetaminophenAlvogen, Inc.ANDACurrent
47781-230Oxycodone and AcetaminophenOxycodone and AcetaminophenAlvogen, Inc.ANDACurrent
47781-230Oxycodone and AcetaminophenOxycodone and AcetaminophenAlvogen, Inc.ANDACurrent
47781-230Oxycodone and AcetaminophenOxycodone and AcetaminophenAlvogen, Inc.ANDACurrent
47781-230Oxycodone and AcetaminophenOxycodone and AcetaminophenAlvogen, Inc.ANDACurrent
47781-230Oxycodone and AcetaminophenOxycodone and AcetaminophenAlvogen, Inc.ANDACurrent
61919-432OXYCODONE/APAPOXYCODONE/APAPDIRECT RXANDACurrent
61919-612OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENDirect rxANDACurrent
61919-612OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENDirect rxANDACurrent
63187-363Oxycodone and AcetaminophenOxycodone and AcetaminophenProficient Rx LPANDACurrent
63187-363Oxycodone and AcetaminophenOxycodone and AcetaminophenProficient Rx LPANDACurrent
63187-719Oxycodone and AcetaminophenOxycodone and AcetaminophenProficient Rx LPANDACurrent
63187-719Oxycodone and AcetaminophenOxycodone and AcetaminophenProficient Rx LPANDACurrent
63629-7748Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
63629-7748Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
63629-7824Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
63629-7824Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
63739-636Oxycodone and AcetaminophenOxycodone and AcetaminophenMcKesson CorporationANDACurrent
63739-739Oxycodone and AcetaminophenOxycodone and AcetaminophenMcKesson CorporationANDACurrent
67296-1773Oxycodone and AcetaminophenOxycodone and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1773Oxycodone and AcetaminophenOxycodone and AcetaminophenRedPharm Drug, Inc.ANDACurrent
68084-699Oxycodone and AcetaminophenOxycodone and AcetaminophenAmerican Health PackagingANDACurrent
68084-699Oxycodone and AcetaminophenOxycodone and AcetaminophenAmerican Health PackagingANDACurrent
68084-699Oxycodone and AcetaminophenOxycodone and AcetaminophenAmerican Health PackagingANDACurrent
68084-699Oxycodone and AcetaminophenOxycodone and AcetaminophenAmerican Health PackagingANDACurrent
68084-710Oxycodone and AcetaminophenOxycodone and AcetaminophenAmerican Health PackagingANDACurrent
68084-710Oxycodone and AcetaminophenOxycodone and AcetaminophenAmerican Health PackagingANDACurrent
68084-710Oxycodone and AcetaminophenOxycodone and AcetaminophenAmerican Health PackagingANDACurrent
68084-710Oxycodone and AcetaminophenOxycodone and AcetaminophenAmerican Health PackagingANDACurrent
71335-0146Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
71335-0146Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
71335-0216Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
71335-0216Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
71335-0316Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
71335-0316Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76331ORIG 2023-11-03