FDA.reportPublic FDA data

Application 040026

Type
ANDA
Sponsor
HI TECH PHARMA

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
50383-801Promethazine HydrochloridePromethazine HydrochlorideHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-801Promethazine HydrochloridePromethazine HydrochlorideAkornANDACurrent
50383-801Promethazine HydrochloridePromethazine HydrochlorideHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-801Promethazine HydrochloridePromethazine HydrochlorideAkornANDACurrent
50383-801Promethazine HydrochloridePromethazine HydrochlorideHi-Tech Pharmacal Co., Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
29890ORIG1998-09-25