FDA.reportPublic FDA data

Application 078974

Type
ANDA
Sponsor
HI TECH PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GABAPENTINGABAPENTINSOLUTION;ORAL250MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17856-0311GabapentinGabapentinAtlantic Biologicals CorpsANDACurrent
17856-1311GabapentinGabapentinAtlantic Biologicals CorpsANDACurrent
50383-311GabapentinGabapentinHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-311GabapentinGabapentinHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-311GabapentinGabapentinAkornANDACurrent
50383-311GabapentinGabapentinHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-350GabapentinGabapentinAkornANDACurrent
50383-350GabapentinGabapentinHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-351GabapentinGabapentinAkornANDACurrent
50383-351GabapentinGabapentinHi-Tech Pharmacal Co., Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9208ORIG2011-02-24