FDA.reportPublic FDA data

Application 090180

Type
ANDA
Sponsor
NOSTRUM LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATECODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDESYRUP;ORAL10MG/5ML;6.25MG/5MLNoNo
002PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATEPROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATESYRUP; ORAL10MG; 5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
12634-907promethazine hydrochloride and codeine phosphatepromethazine hydrochloride and codeine phosphateApotheca Inc.ANDACurrent
63187-595promethazine hydrochloride and codeine phosphatepromethazine hydrochloride and codeine phosphateProficient Rx LPANDACurrent
70408-185promethazine hydrochloride and codeine phosphatepromethazine hydrochloride and codeine phosphateNostrum Laboratories, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9261ORIG2010-03-22