FDA.reportPublic FDA data

Application 040330

Type
ANDA
Sponsor
VINTAGE PHARMS LLC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
12634-942Oxycodone and AcetaminophenOxycodone and AcetaminophenApotheca, IncANDACurrent
60951-602ENDOCETOxycodone and AcetaminophenPar PharmaceuticalANDACurrent
60951-602ENDOCETOxycodone and AcetaminophenPar Pharmaceutical, Inc.ANDACurrent
60951-602ENDOCETOxycodone and AcetaminophenPar Pharmaceutical, Inc.ANDACurrent
60951-700ENDOCETOxycodone and AcetaminophenPar PharmaceuticalANDACurrent
60951-700ENDOCETOxycodone and AcetaminophenPar Pharmaceutical, Inc.ANDACurrent
60951-700ENDOCETOxycodone and AcetaminophenPar Pharmaceutical, Inc.ANDACurrent
60951-701ENDOCETOxycodone and AcetaminophenPar PharmaceuticalANDACurrent
60951-701ENDOCETOxycodone and AcetaminophenPar Pharmaceutical, Inc.ANDACurrent
60951-701ENDOCETOxycodone and AcetaminophenPar Pharmaceutical, Inc.ANDACurrent
60951-712ENDOCETOxycodone and AcetaminophenPar PharmaceuticalANDACurrent
60951-712ENDOCETOxycodone and AcetaminophenPar Pharmaceutical, Inc.ANDACurrent
60951-712ENDOCETOxycodone and AcetaminophenPar Pharmaceutical, Inc.ANDACurrent
63481-623PERCOCEToxycodone hydrochloride and acetaminophenEndo Pharmaceuticals Inc.ANDACurrent
63481-623PERCOCEToxycodone hydrochloride and acetaminophenEndo Pharmaceuticals, Inc.ANDACurrent
63481-623PERCOCEToxycodone hydrochloride and acetaminophenEndo Pharmaceuticals Inc.ANDACurrent
63481-627PERCOCEToxycodone hydrochloride and acetaminophenEndo Pharmaceuticals Inc.ANDACurrent
63481-627PERCOCEToxycodone hydrochloride and acetaminophenEndo Pharmaceuticals, Inc.ANDACurrent
63481-627PERCOCEToxycodone hydrochloride and acetaminophenEndo Pharmaceuticals Inc.ANDACurrent
63481-628PERCOCEToxycodone hydrochloride and acetaminophenEndo Pharmaceuticals Inc.ANDACurrent
63481-628PERCOCEToxycodone hydrochloride and acetaminophenEndo Pharmaceuticals, Inc.ANDACurrent
63481-628PERCOCEToxycodone hydrochloride and acetaminophenEndo Pharmaceuticals Inc.ANDACurrent
63481-629PERCOCEToxycodone hydrochloride and acetaminophenEndo Pharmaceuticals Inc.ANDACurrent
63481-629PERCOCEToxycodone hydrochloride and acetaminophenEndo Pharmaceuticals, Inc.ANDACurrent
63481-629PERCOCEToxycodone hydrochloride and acetaminophenEndo Pharmaceuticals Inc.ANDACurrent
63629-2187ENDOCETOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2187ENDOCETOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2188ENDOCETOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2188ENDOCETOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2189ENDOCETOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2189ENDOCETOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2190ENDOCETOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2190ENDOCETOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
65084-298PERCOCEToxycodone hydrochloride and acetaminophenMckesson Rxpak IncANDACurrent
71335-2182ENDOCETOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76186ORIG 2023-11-03
59118SUPPL2019-06-19
59117SUPPL2019-06-19
38884SUPPL2006-11-30
22127ORIG1999-06-25
7625ORIG1999-06-25