FDA.reportPublic FDA data

Application 040777

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-621Oxycodone and AcetaminophenOxycodone and AcetaminophenBlenheim Pharmacal, Inc.ANDACurrent
35356-817Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
45865-860Oxycodone and AcetaminophenOxycodone and AcetaminophenMedsource PharmaceuticalsANDACurrent
50268-644Oxycodone and AcetaminophenOxycodone and AcetaminophenAvPAKANDACurrent
50268-644Oxycodone and AcetaminophenOxycodone and AcetaminophenAvPAKANDACurrent
50436-0203Oxycodone and AcetaminophenOxycodone and AcetaminophenUnit Dose ServicesANDACurrent
53746-203Oxycodone and AcetaminophenOxycodone and AcetaminophenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-203Oxycodone and AcetaminophenOxycodone and AcetaminophenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-203Oxycodone and AcetaminophenOxycodone and AcetaminophenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-203Oxycodone and AcetaminophenOxycodone and AcetaminophenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-203Oxycodone and AcetaminophenOxycodone and AcetaminophenAmneal Pharmaceuticals of New York LLCANDACurrent
60760-200Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and AcetaminophenSt. Mary's Medical Park PharmacyANDACurrent
61919-614OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENDIRECT RXANDACurrent
63739-709Oxycodone and AcetaminophenOxycodone and AcetaminophenMcKesson Corporation dba SKY PackagingANDACurrent
63739-709Oxycodone and AcetaminophenOxycodone and AcetaminophenMcKesson CorporationANDACurrent
67296-0522Oxycodone and AcetaminophenOxycodone and AcetaminophenRedPharm Drug Inc.ANDACurrent
68084-355Oxycodone and AcetaminophenOxycodone and AcetaminophenAmerican Health PackagingANDACurrent
68084-355Oxycodone and AcetaminophenOxycodone and AcetaminophenAmerican Health PackagingANDACurrent
68084-355Oxycodone and AcetaminophenOxycodone and AcetaminophenAmerican Health PackagingANDACurrent
68084-355Oxycodone and AcetaminophenOxycodone and AcetaminophenAmerican Health PackagingANDACurrent
68084-355Oxycodone and AcetaminophenOxycodone and AcetaminophenAmerican Health PackagingANDACurrent
68094-013Oxycodone and AcetaminophenOxycodone Hydrochloride and AcetaminophenPrecision Dose, Inc.ANDACurrent
71335-0193Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
71335-0193Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
71335-0193Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76299ORIG 2023-11-03