FDA.reportPublic FDA data

Application 040737

Type
ANDA
Sponsor
XGEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEINJECTABLE;INJECTION25MG/MLNoNo
002PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEINJECTABLE;INJECTION50MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
39822-5525PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEX-GEN Pharmaceuticals, Inc.ANDACurrent
39822-5525PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEXGen Pharmaceuticals DJB, Inc.ANDACurrent
39822-5525PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEX-GEN Pharmaceuticals, Inc.ANDACurrent
39822-5550PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEXGen Pharmaceuticals DJB, Inc.ANDACurrent
39822-5550PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEX-GEN Pharmaceuticals, Inc.ANDACurrent
39822-5550PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEX-GEN Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44196ORIG2008-05-02