FDA.reportPublic FDA data

Application 076392

Type
ANDA
Sponsor
BARR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MEFLOQUINE HYDROCHLORIDEMEFLOQUINE HYDROCHLORIDETABLET;ORAL250MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0555-0171Mefloquine HydrochlorideMefloquine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0171Mefloquine HydrochlorideMefloquine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0171Mefloquine HydrochlorideMefloquine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0171Mefloquine HydrochlorideMefloquine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
21695-449Mefloquine HydrochlorideMefloquine HydrochlorideRebel Distributors CorpANDACurrent
50090-2396Mefloquine HydrochlorideMefloquine HydrochlorideA-S Medication SolutionsANDACurrent
50090-2396Mefloquine HydrochlorideMefloquine HydrochlorideA-S Medication SolutionsANDACurrent
68071-4702Mefloquine HydrochlorideMefloquine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4702Mefloquine HydrochlorideMefloquine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-6833Mefloquine HydrochlorideMefloquine HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6833Mefloquine HydrochlorideMefloquine HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6833Mefloquine HydrochlorideMefloquine HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18448SUPPL2013-07-29