Application 086557

Type
ANDA
Sponsor
COSETTE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MIGERGOTCAFFEINE; ERGOTAMINE TARTRATESUPPOSITORY;RECTAL100MG;2MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0713-0166MIGERGOTErgotamine Tartrate and CaffeineG&W Laboratories, Inc.ANDACurrent
0713-0166MIGERGOTErgotamine Tartrate and CaffeineCosette Pharmaceuticals, Inc.ANDACurrent
0713-0166MIGERGOTErgotamine Tartrate and CaffeineCosette Pharmaceuticals, Inc.ANDACurrent
75987-090Migergotergotamine tartrate and caffeineHorizon Pharma Inc.ANDACurrent