FDA.reportPublic FDA data

Application 077858

Type
ANDA
Sponsor
MYLAN

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
0378-8088Tramadol Hydrochloride and Acetaminophentramadol hydrochloride and acetaminophenMylan Pharmaceuticals Inc.ANDACurrent
0378-8088Tramadol Hydrochloride and Acetaminophentramadol hydrochloride and acetaminophenMylan Pharmaceuticals Inc.ANDACurrent
0378-8088Tramadol Hydrochloride and Acetaminophentramadol hydrochloride and acetaminophenMylan Pharmaceuticals Inc.ANDACurrent
0378-8088Tramadol Hydrochloride and Acetaminophentramadol hydrochloride and acetaminophenMylan Pharmaceuticals Inc.ANDACurrent
68788-7652Tramadol Hydrochloride and Acetaminophentramadol hydrochloride and acetaminophenPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9267Tramadol Hydrochloride and Acetaminophentramadol hydrochloride and acetaminophenPreferred PharmaceuticalsANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76123ORIG 2023-11-03
9091ORIG2008-10-01