FDA.reportPublic FDA data

Application 211825

Type
ANDA
Sponsor
UNICHEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDETABLET;ORAL50MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
29300-355Tramadol HydrochlorideTramadol HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-355Tramadol HydrochlorideTramadol HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-355Tramadol HydrochlorideTramadol HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-355Tramadol HydrochlorideTramadol HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-355Tramadol HydrochlorideTramadol HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
50090-5789Tramadol HydrochlorideTramadol HydrochlorideA-S Medication SolutionsANDACurrent
50090-5790Tramadol HydrochlorideTramadol HydrochlorideA-S Medication SolutionsANDACurrent
50090-5790Tramadol HydrochlorideTramadol HydrochlorideA-S Medication SolutionsANDACurrent
50090-5790Tramadol HydrochlorideTramadol HydrochlorideA-S Medication SolutionsANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76471ORIG 2023-11-07