FDA.reportPublic FDA data

Application 090485

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENACETAMINOPHEN; TRAMADOL HYDROCHLORIDETABLET;ORAL325MG;37.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
33261-389Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenAidarex Pharmaceuticals LLCANDACurrent
33358-343Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenRxChange Co.ANDACurrent
42254-051Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenRebel Distributors CorpANDACurrent
42291-832Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenAvKARE, Inc.ANDACurrent
42291-832Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenAvKAREANDACurrent
45865-469Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenMedsource PharmaceuticalsANDACurrent
45865-469Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenMedsource PharmaceuticalsANDACurrent
50090-0919Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenA-S Medication SolutionsANDACurrent
50090-0919Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenA-S Medication SolutionsANDACurrent
50268-774Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenAvPAKANDACurrent
50268-774Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenAvPAKANDACurrent
50436-6291Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenUnit Dose ServicesANDACurrent
53217-040Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenAidarex Pharmaceuticals LLCANDACurrent
53746-617Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-617Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-617Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenAmneal Pharmaceuticals of New York, LLCANDACurrent
53746-617Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-617Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenAmneal Pharmaceuticals of New York LLCANDACurrent
55700-124Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-124Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
61919-067TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENDirect RxANDACurrent
61919-230TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENDIRECT RXANDACurrent
61919-230TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENDIRECT RXANDACurrent
63187-084Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenProficient Rx LPANDACurrent
63187-084Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenProficient Rx LPANDACurrent
63629-3406Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenBryant Ranch PrepackANDACurrent
63629-4901Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenBryant Ranch PrepackANDACurrent
63629-4901Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenBryant Ranch PrepackANDACurrent
65162-617Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenAmneal Pharmaceuticals LLCANDACurrent
65162-617Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenAmneal Pharmaceuticals LLCANDACurrent
65162-617Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenAmneal Pharmaceuticals LLCANDACurrent
65162-617Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenAmneal Pharmaceuticals LLCANDACurrent
65162-617Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenAmneal Pharmaceuticals LLCANDACurrent
68788-0985Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7855Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenPreferred Pharmaceuticals Inc.ANDACurrent
68788-7855Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenPreferred Pharmaceuticals Inc.ANDACurrent
71335-0111Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenBryant Ranch PrepackANDACurrent
71335-0111Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenBryant Ranch PrepackANDACurrent
71335-0111Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenBryant Ranch PrepackANDACurrent
71335-0111Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenBryant Ranch PrepackANDACurrent
76420-983Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenAsclemed USA, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76318ORIG 2023-11-03