FDA.reportPublic FDA data

Application 074509

Type
ANDA
Sponsor
PHARM ASSOC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDESYRUP;ORAL50MG/5MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0121-0646AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDEPharmaceutical Associates, Inc.ANDACurrent
0121-0646AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDEPharmaceutical Associates, Inc.ANDACurrent
0121-0646AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDEPharmaceutical Associates, Inc.ANDACurrent
0121-0646AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDEPharmaceutical Associates, Inc.ANDACurrent
0121-0646AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDEPharmaceutical Associates, Inc.ANDACurrent
17856-0646AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDEATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0646AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDEATLANTIC BIOLOGICALS CORP.ANDACurrent
50436-0646AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDEUnit Dose ServicesANDACurrent
55154-9444AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDECardinal Health, Inc.ANDACurrent
55154-9444AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDECardinal HealthANDACurrent
55154-9444AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDECardinal HealthANDACurrent
55154-9444AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDECardinal Health 107, LLCANDACurrent
68151-0910AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDECarilion Materials ManagementANDACurrent