FDA.reportPublic FDA data

Application 074664

Type
ANDA
Sponsor
HI TECH PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CIMETIDINE HYDROCHLORIDECIMETIDINE HYDROCHLORIDESOLUTION;ORALEQ 300MG BASE/5MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50383-050Cimetidine Hydrochloride Oral SolutionCimetidine Hydrochloride Oral SolutionAkorn Operating Company LLCANDACurrent
50383-050Cimetidine Hydrochloride Oral SolutionCimetidine Hydrochloride Oral SolutionHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-050Cimetidine Hydrochloride Oral SolutionCimetidine Hydrochloride Oral SolutionHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-966CIMETIDINE HYDROCHLORIDECIMETIDINE HYDROCHLORIDEAkornANDACurrent
50383-966CIMETIDINE HYDROCHLORIDECIMETIDINE HYDROCHLORIDEHi-Tech Pharmacal Co., Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42859ORIG2005-07-22
76423ORIG 2004-05-26
8429ORIG2004-05-26