FDA.reportPublic FDA data

Application 040643

Type
ANDA
Sponsor
VINTAGE

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0121-0927Promethazine HydrochloridePromethazine HydrochloridePharmaceutical Associates, Inc.ANDACurrent
0121-0927Promethazine HydrochloridePromethazine HydrochloridePharmaceutical Associates, Inc.ANDACurrent
0121-0927Promethazine HydrochloridePromethazine HydrochloridePharmaceutical Associates, Inc.ANDACurrent
0121-0927Promethazine HydrochloridePromethazine HydrochloridePharmaceutical Associates, Inc.ANDACurrent
0603-1584Promethazine HydrochloridePromethazine HydrochloridePar PharmaceuticalANDACurrent
0603-1584Promethazine HydrochloridePromethazine HydrochloridePar PharmaceuticalANDACurrent
50090-0222Promethazine HydrochloridePromethazine HydrochlorideA-S Medication SolutionsANDACurrent
55045-1643Promethazine HydrochloridePromethazine HydrochlorideDispensing Solutions, Inc.ANDACurrent
68071-1767Promethazine HydrochloridePromethazine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4137Promethazine HydrochloridePromethazine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68151-1584Promethazine HydrochloridePromethazine HydrochlorideCarilion Materials ManagementANDACurrent
68788-7028Promethazine HydrochloridePromethazine HydrochloridePreferred Pharmaceutical Inc.ANDACurrent
68788-7028Promethazine HydrochloridePromethazine HydrochloridePreferred Pharmaceutical Inc.ANDACurrent
68788-8162Promethazine HydrochloridePromethazine HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44193ORIG2006-05-03