FDA.reportPublic FDA data

Application 210001

Type
ANDA
Sponsor
BIONPHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZITHROMYCINAZITHROMYCINTABLET;ORALEQ 500MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42291-083AzithromycinAzithromycinAvKAREANDACurrent
43986-007AzithromycinAzithromycinBluepharma - Industria Farmaceutica, S.A.ANDACurrent
68071-2297AzithromycinAzithromycinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2297AzithromycinAzithromycinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2507AzithromycinAzithromycinNuCare Pharmaceuticals,Inc.ANDACurrent
69452-172AzithromycinAzithromycinBionpharma Inc.ANDACurrent
69452-172AzithromycinAzithromycinBionpharma Inc.ANDACurrent
70518-3169AzithromycinAzithromycinREMEDYREPACK INC.ANDACurrent
71205-503AzithromycinAzithromycinProficient Rx LPANDACurrent
71205-503AzithromycinAzithromycinProficient Rx LPANDACurrent
71335-1755AzithromycinAzithromycinBryant Ranch PrepackANDACurrent
72189-088AZITHROMYCINAZITHROMYCINDIRECT RXANDACurrent
72189-088AZITHROMYCINAZITHROMYCINDIRECT RXANDACurrent
72189-088AZITHROMYCINAZITHROMYCINDIRECT RXANDACurrent