FDA.reportPublic FDA data

Application 040500

Type
ANDA
Sponsor
PERRIGO ISRAEL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDESUPPOSITORY;RECTAL12.5MGNoNo
002PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDESUPPOSITORY;RECTAL25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-649Promethazine HydrochloridePromethazine HydrochlorideRebel Distributors CorpANDACurrent
43063-060Promethazine HydrochloridePromethazine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-060Promethazine HydrochloridePromethazine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-060Promethazine HydrochloridePromethazine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-060Promethazine HydrochloridePromethazine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-060Promethazine HydrochloridePromethazine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-060Promethazine HydrochloridePromethazine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
45802-758Promethazine HydrochloridePromethazine HydrochloridePerrigo New York IncANDACurrent
45802-758Promethazine HydrochloridePromethazine HydrochloridePadagis Israel Pharmaceuticals LtdANDACurrent
45802-758Promethazine HydrochloridePromethazine HydrochloridePerrigo New York IncANDACurrent
45802-758Promethazine HydrochloridePromethazine HydrochloridePerrigo New York IncANDACurrent
45802-759Promethazine HydrochloridePromethazine HydrochloridePerrigo New York IncANDACurrent
45802-759Promethazine HydrochloridePromethazine HydrochloridePerrigo New York IncANDACurrent
45802-759Promethazine HydrochloridePromethazine HydrochloridePadagis Israel Pharmaceuticals LtdANDACurrent
45802-759Promethazine HydrochloridePromethazine HydrochloridePerrigo New York IncANDACurrent
50090-2747Promethazine HydrochloridePromethazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-2747Promethazine HydrochloridePromethazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-2747Promethazine HydrochloridePromethazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-2986Promethazine HydrochloridePromethazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-2986Promethazine HydrochloridePromethazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-2986Promethazine HydrochloridePromethazine HydrochlorideA-S Medication SolutionsANDACurrent
63629-8445Promethazine HydrochloridePromethazine HydrochlorideBryant Ranch PrepackANDACurrent
63629-8445Promethazine HydrochloridePromethazine HydrochlorideBryant Ranch PrepackANDACurrent
63629-8445Promethazine HydrochloridePromethazine HydrochlorideBryant Ranch PrepackANDACurrent
63629-8446Promethazine HydrochloridePromethazine HydrochlorideBryant Ranch PrepackANDACurrent
63629-8446Promethazine HydrochloridePromethazine HydrochlorideBryant Ranch PrepackANDACurrent
63629-8446Promethazine HydrochloridePromethazine HydrochlorideBryant Ranch PrepackANDACurrent