FDA.reportPublic FDA data

Application 065225

Type
ANDA
Sponsor
PLIVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZITHROMYCINAZITHROMYCINTABLET;ORALEQ 250MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
33261-139AzithromycinAzithromycinAidarex Pharmaceuticals LLCANDACurrent
45865-536AzithromycinAzithromycinMedsource PharmaceuticalsANDACurrent
50090-1788AzithromycinAzithromycinA-S Medication SolutionsANDACurrent
50090-3213AzithromycinAzithromycinA-S Medication SolutionsANDACurrent
50111-787AzithromycinAzithromycinTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-787AzithromycinAzithromycinTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-787AzithromycinAzithromycinTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-787AzithromycinAzithromycinTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-787AzithromycinAzithromycinTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-787AzithromycinAzithromycinTeva Pharmaceuticals USA, Inc.ANDACurrent
50436-0787AzithromycinAzithromycinUnit Dose ServicesANDACurrent
51655-897AzithromycinAzithromycinNorthwind PharmaceuticalsANDACurrent
53002-2224AzithromycinAzithromycinRPK Pharmaceuticals, Inc.ANDACurrent
53002-2224AzithromycinAzithromycinRPK Pharmaceuticals, Inc.ANDACurrent
53002-2228AzithromycinAzithromycinRPK Pharmaceuticals, Inc.ANDACurrent
53002-2228AzithromycinAzithromycinRPK Pharmaceuticals, Inc.ANDACurrent
53217-263AzithromycinAzithromycinAidarex Pharmaceuticals LLCANDACurrent
54348-857AzithromycinAZITHROMYCIN MONOHYDRATEPharmPak, Inc.ANDACurrent
54348-857AzithromycinAZITHROMYCIN MONOHYDRATEPharmPak, Inc.ANDACurrent
55700-065AzithromycinAzithromycinLake Erie Medical DBA Quality Care Products LLCANDACurrent
61919-260AZITHROMYCIN MONOHYDRATEAZITHROMYCIN MONOHYDRATEDIRECT RXANDACurrent
63187-007AzithromycinAzithromycinProficient Rx LPANDACurrent
63187-007AzithromycinAzithromycinProficient Rx LPANDACurrent
63187-007AzithromycinAzithromycinProficient Rx LPANDACurrent
63187-007AzithromycinAzithromycinProficient Rx LPANDACurrent
63187-007AzithromycinAzithromycinProficient Rx LPANDACurrent
63187-007AzithromycinAzithromycinProficient Rx LPANDACurrent
63187-007AzithromycinAzithromycinProficient Rx LPANDACurrent
63187-189AzithromycinAzithromycinProficient Rx LPANDACurrent
63187-189AzithromycinAzithromycinProficient Rx LPANDACurrent
63187-189AzithromycinAzithromycinProficient Rx LPANDACurrent
63187-189AzithromycinAzithromycinProficient Rx LPANDACurrent
63187-189AzithromycinAzithromycinProficient Rx LPANDACurrent
63187-189AzithromycinAzithromycinProficient Rx LPANDACurrent
68071-1323AzithromycinAzithromycinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1323AzithromycinAzithromycinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2622AzithromycinAzithromycinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4106AzithromycinAzithromycinNuCare Pharmaceuticals,Inc.ANDACurrent
68788-9977AzithromycinAzithromycinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9977AzithromycinAzithromycinPreferred Pharmaceuticals, Inc.ANDACurrent
70518-0784AzithromycinAzithromycinREMEDYREPACK INC.ANDACurrent
70518-0784AzithromycinAzithromycinREMEDYREPACK INC.ANDACurrent
70518-0784AzithromycinAzithromycinREMEDYREPACK INC.ANDACurrent
70518-0784AzithromycinAzithromycinREMEDYREPACK INC.ANDACurrent
70518-0784AzithromycinAzithromycinREMEDYREPACK INC.ANDACurrent
70518-0784AzithromycinAzithromycinREMEDYREPACK INC.ANDACurrent
70518-0784AzithromycinAzithromycinREMEDYREPACK INC.ANDACurrent
76413-153AzithromycinAzithromycinCentral Texas Community Health CentersANDACurrent
76420-006AzithromycinAzithromycinAsclemed USA, Inc.ANDACurrent
76420-006AzithromycinAzithromycinAsclemed USA, Inc.ANDACurrent
80425-0219AzithromycinAzithromycinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent