FDA.reportPublic FDA data

Application 087953

Type
ANDA
Sponsor
WOCKHARDT BIO AG

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROMETHAZINE PLAINPROMETHAZINE HYDROCHLORIDESYRUP;ORAL6.25MG/5MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17856-0608Promethazine HydrochloridePromethazine HydrochlorideAtlantic Biologicals CorpsANDACurrent
17856-0608Promethazine HydrochloridePromethazine HydrochlorideATLANTIC BIOLOGICALS CORP.ANDACurrent
21695-703Promethazine HydrochloridePromethazine HydrochlorideRebel Distributors CorpANDACurrent
50090-4124PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideA-S Medication SolutionsANDACurrent
50090-4124PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideA-S Medication SolutionsANDACurrent
60432-608PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideMorton Grove Pharmaceuticals, Inc.ANDACurrent
60432-608PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideMorton Grove Pharmaceuticals, Inc.ANDACurrent
63187-338Promethazine HydrochloridePromethazine HydrochlorideProficient Rx LPANDACurrent