FDA.reportPublic FDA data

Application 040778

Type
ANDA
Sponsor
AMNEAL PHARMS NY

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-619Oxycodone and AcetaminophenOxycodone and AcetaminophenRebel Distributors CorpANDACurrent
35356-937Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
42291-646Oxycodone and AcetaminophenOxycodone and AcetaminophenAvKARE, Inc.ANDACurrent
50268-645Oxycodone and AcetaminophenOxycodone and AcetaminophenAvPAKANDACurrent
50268-645Oxycodone and AcetaminophenOxycodone and AcetaminophenAvPAKANDACurrent
50268-646Oxycodone and AcetaminophenOxycodone and AcetaminophenAvPAKANDACurrent
50268-646Oxycodone and AcetaminophenOxycodone and AcetaminophenAvPAKANDACurrent
52959-119Oxycodone and AcetaminophenOxycodone and AcetaminophenH.J. Harkins Company, Inc.ANDACurrent
53746-204Oxycodone and AcetaminophenOxycodone and AcetaminophenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-204Oxycodone and AcetaminophenOxycodone and AcetaminophenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-204Oxycodone and AcetaminophenOxycodone and AcetaminophenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-204Oxycodone and AcetaminophenOxycodone and AcetaminophenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-204Oxycodone and AcetaminophenOxycodone and AcetaminophenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-204Oxycodone and AcetaminophenOxycodone and AcetaminophenAmneal Pharmaceuticals of New York LLCANDACurrent
55700-373Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
61502-915OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENEPM Packaging IncANDACurrent
61919-475OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHEDirect_RxANDACurrent
61919-615OXYCODONE APAPOXYCODONE APAPDIRECT RXANDACurrent
63187-721Oxycodone and AcetaminophenOxycodone and AcetaminophenProficient Rx LPANDACurrent
63187-721Oxycodone and AcetaminophenOxycodone and AcetaminophenProficient Rx LPANDACurrent
63739-217Oxycodone and AcetaminophenOxycodone and AcetaminophenMcKesson CorporationANDACurrent
63739-217Oxycodone and AcetaminophenOxycodone and AcetaminophenMcKesson Corporation dba SKY PackagingANDACurrent
65162-207Oxycodone and AcetaminophenOxycodone and AcetaminophenAmneal Pharmaceuticals LLCANDACurrent
65162-207Oxycodone and AcetaminophenOxycodone and AcetaminophenAmneal Pharmaceuticals LLCANDACurrent
65162-207Oxycodone and AcetaminophenOxycodone and AcetaminophenAmneal Pharmaceuticals LLCANDACurrent
65162-207Oxycodone and AcetaminophenOxycodone and AcetaminophenAmneal Pharmaceuticals LLCANDACurrent
65162-207Oxycodone and AcetaminophenOxycodone and AcetaminophenAmneal Pharmaceuticals LLCANDACurrent
65162-207Oxycodone and AcetaminophenOxycodone and AcetaminophenAmneal Pharmaceuticals LLCANDACurrent
65162-207Oxycodone and AcetaminophenOxycodone and AcetaminophenAmneal Pharmaceuticals LLCANDACurrent
65162-207Oxycodone and AcetaminophenOxycodone and AcetaminophenAmneal Pharmaceuticals LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76300ORIG 2023-11-03