FDA.reportPublic FDA data

Application 076403

Type
ANDA
Sponsor
ACELLA PHARMS LLC

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
17856-0600GabapentingabapentinATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0600GabapentingabapentinATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0600GabapentingabapentinATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0600GabapentingabapentinATLANTIC BIOLOGICALS CORP.ANDACurrent
42192-608GabapentingabapentinAcella Pharmaceuticals, LLCANDACurrent
42192-608GabapentingabapentinAcella Pharmaceuticals, LLCANDACurrent
42192-608GabapentingabapentinAcella Pharmaceuticals, LLCANDACurrent
42192-608GabapentingabapentinAcella Pharmaceuticals, LLCANDACurrent
42192-608GabapentingabapentinAcella Pharmaceuticals, LLCANDACurrent
42192-608GabapentingabapentinAcella Pharmaceuticals, LLCANDACurrent
59063-127GabapentingabapentinKiel Laboratories, Inc.ANDACurrent
70166-751GabapentingabapentinLohxaANDACurrent
70166-751GabapentingabapentinLohxaANDACurrent