FDA.reportPublic FDA data

Application 078720

Type
ANDA
Sponsor
BIONPHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDECAPSULE;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0527-1704Amantadine HydrochlorideAmantadine HydrochlorideLannett Company, Inc.ANDACurrent
0527-1704Amantadine HydrochlorideAmantadine HydrochlorideLannett Company, Inc.ANDACurrent
10888-5006Amantadine HClAMANTADINE HYDROCHLORIDEBanner Pharmacaps IncANDACurrent
21695-564Amantadine HClAmantadine hydrochlorideRebel Distributors Corp.ANDACurrent
42291-125Amantadine HClAMANTADINE HYDROCHLORIDEAvKARE, Inc.ANDACurrent
42291-125Amantadine HClAMANTADINE HYDROCHLORIDEAvKARE, Inc.ANDACurrent
42291-125Amantadine HClAMANTADINE HYDROCHLORIDEAvKAREANDACurrent
50268-069Amantadine HClAMANTADINE HYDROCHLORIDEAvPAKANDACurrent
50268-069Amantadine HClAMANTADINE HYDROCHLORIDEAvPAKANDACurrent
50268-069Amantadine HClAMANTADINE HYDROCHLORIDEAvPAKANDACurrent
53808-0933Amantadine HClAMANTADINE HYDROCHLORIDEState of Florida DOH Central PharmacyANDACurrent
63629-2681Amantadine HClAmantadine hydrochlorideBryant Ranch PrepackANDACurrent
68788-9530Amantadine HClAMANTADINE HYDROCHLORIDEPreferred Pharmaceuticals, Inc.ANDACurrent
69387-100Amantadine HClAMANTADINE HYDROCHLORIDEBanner Life Sciences LLC.ANDACurrent
69452-142Amantadine HClAMANTADINE HYDROCHLORIDEBionpharma Inc.ANDACurrent
71335-0279Amantadine HClAMANTADINE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71335-0279Amantadine HClAMANTADINE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71335-0279Amantadine HClAMANTADINE HYDROCHLORIDEBryant Ranch PrepackANDACurrent