FDA.reportPublic FDA data

Application 201972

Type
ANDA
Sponsor
AUROLIFE PHARMA LLC

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
13107-043Oxycodone and AcetaminophenOxycodone and AcetaminophenAurolife Pharma LLCANDACurrent
13107-043Oxycodone and AcetaminophenOxycodone and AcetaminophenAurolife Pharma LLCANDACurrent
13107-043Oxycodone and AcetaminophenOxycodone and AcetaminophenAurolife Pharma, LLCANDACurrent
13107-043Oxycodone and AcetaminophenOxycodone and AcetaminophenAurolife Pharma, LLCANDACurrent
13107-044Oxycodone and AcetaminophenOxycodone and AcetaminophenAurolife Pharma LLCANDACurrent
13107-044Oxycodone and AcetaminophenOxycodone and AcetaminophenAurolife Pharma LLCANDACurrent
13107-044Oxycodone and AcetaminophenOxycodone and AcetaminophenAurolife Pharma, LLCANDACurrent
13107-044Oxycodone and AcetaminophenOxycodone and AcetaminophenAurolife Pharma, LLCANDACurrent
13107-045Oxycodone and AcetaminophenOxycodone and AcetaminophenAurolife Pharma LLCANDACurrent
13107-045Oxycodone and AcetaminophenOxycodone and AcetaminophenAurolife Pharma LLCANDACurrent
13107-045Oxycodone and AcetaminophenOxycodone and AcetaminophenAurolife Pharma, LLCANDACurrent
13107-045Oxycodone and AcetaminophenOxycodone and AcetaminophenAurolife Pharma, LLCANDACurrent
13107-046Oxycodone and AcetaminophenOxycodone and AcetaminophenAurolife Pharma LLCANDACurrent
13107-046Oxycodone and AcetaminophenOxycodone and AcetaminophenAurolife Pharma, LLCANDACurrent
13107-046Oxycodone and AcetaminophenOxycodone and AcetaminophenAurolife Pharma, LLCANDACurrent
13107-046Oxycodone and AcetaminophenOxycodone and AcetaminophenAurolife Pharma LLCANDACurrent
55700-496Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-496Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-496Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-496Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-496Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-496Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-496Oxycodone and AcetaminophenOxycodone and AcetaminophenQuality Care Products LLCANDACurrent
55700-496Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-496Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA QuaANDACurrent
55700-496Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-496Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-496Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-496Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-496Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-496Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-496Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-497Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-497Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-497Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-497Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-497Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-497Oxycodone and AcetaminophenOxycodone and AcetaminophenQuality Care Products LLCANDACurrent
55700-497Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-497Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA QuaANDACurrent
55700-497Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-497Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-497Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-497Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-497Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-497Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-497Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-497Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-498Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-498Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-498Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-498Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-498Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-498Oxycodone and AcetaminophenOxycodone and AcetaminophenQuality Care Products LLCANDACurrent
55700-498Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-498Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA QuaANDACurrent
55700-498Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-498Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-498Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-498Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-498Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-498Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-498Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-498Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
60760-274Oxycodone and AcetaminophenOxycodone and AcetaminophenSt. Mary's Medical Park PharmacyANDACurrent
60760-276Oxycodone and AcetaminophenOxycodone and AcetaminophenSt. Mary's Medical Park PharmacyANDACurrent
61919-412OXYCODONE APAPOXYCODONE APAPDIRECT RXANDACurrent
61919-412OXYCODONE APAPOXYCODONE APAPDIRECT RXANDACurrent
61919-437OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHEDIRECT RXANDACurrent
61919-437OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHEDIRECT RXANDACurrent
61919-524OXYCODONE/APAPOXYCODONE/APAPDirectRXANDACurrent
63187-823Oxycodone and AcetaminophenOxycodone and AcetaminophenProficient Rx LPANDACurrent
63187-823Oxycodone and AcetaminophenOxycodone and AcetaminophenProficient Rx LPANDACurrent
63187-984Oxycodone and AcetaminophenOxycodone and AcetaminophenProficient Rx LPANDACurrent
63187-984Oxycodone and AcetaminophenOxycodone and AcetaminophenProficient Rx LPANDACurrent
67296-1392Oxycodone and AcetaminophenOxycodone and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1392Oxycodone and AcetaminophenOxycodone and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1392Oxycodone and AcetaminophenOxycodone and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1392Oxycodone and AcetaminophenOxycodone and AcetaminophenRedPharm Drug, Inc.ANDACurrent
71335-1036Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76326ORIG 2023-11-03