FDA.reportPublic FDA data

Application 065489

Type
ANDA
Sponsor
AUROBINDO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLARITHROMYCINCLARITHROMYCINTABLET;ORAL250MGNoYes
002CLARITHROMYCINCLARITHROMYCINTABLET;ORAL500MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6872ClarithromycinClarithromycinMajor PharmaceuticalsANDACurrent
0904-6872ClarithromycinClarithromycinMajor PharmaceuticalsANDACurrent
43063-823ClarithromycinClarithromycinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-823ClarithromycinClarithromycinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-823ClarithromycinClarithromycinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-823ClarithromycinClarithromycinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-823ClarithromycinClarithromycinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-823ClarithromycinClarithromycinPD-Rx Pharmaceuticals, InANDACurrent
50090-1830ClarithromycinClarithromycinA-S Medication SolutionsANDACurrent
50090-1830ClarithromycinClarithromycinA-S Medication SolutionsANDACurrent
50090-1830ClarithromycinClarithromycinA-S Medication SolutionsANDACurrent
50268-178ClarithromycinClarithromycinAvPAKANDACurrent
50268-178ClarithromycinClarithromycinAvPAKANDACurrent
50268-178ClarithromycinClarithromycinAvPAKANDACurrent
50268-179ClarithromycinClarithromycinAvPAKANDACurrent
50268-179ClarithromycinClarithromycinAvPAKANDACurrent
50268-179ClarithromycinClarithromycinAvPAKANDACurrent
57237-044ClarithromycinClarithromycinRising Health, LLCANDACurrent
57237-044ClarithromycinClarithromycinRising Health, LLCANDACurrent
57237-044ClarithromycinClarithromycinRising Health, LLCANDACurrent
57237-044ClarithromycinClarithromycinRising Health, LLCANDACurrent
57237-044ClarithromycinClarithromycinRising Health, LLCANDACurrent
57237-045ClarithromycinClarithromycinRising Health, LLCANDACurrent
57237-045ClarithromycinClarithromycinRising Health, LLCANDACurrent
57237-045ClarithromycinClarithromycinRising Health, LLCANDACurrent
57237-045ClarithromycinClarithromycinRising Health, LLCANDACurrent
57237-045ClarithromycinClarithromycinRising Health, LLCANDACurrent
63187-625ClarithromycinClarithromycinProficient Rx LPANDACurrent
63187-625ClarithromycinClarithromycinProficient Rx LPANDACurrent
65862-225ClarithromycinClarithromycinAurobindo Pharma LimitedANDACurrent
65862-225ClarithromycinClarithromycinAurobindo Pharma LimitedANDACurrent
65862-225ClarithromycinClarithromycinAurobindo Pharma LimitedANDACurrent
65862-225ClarithromycinClarithromycinAurobindo Pharma LimitedANDACurrent
65862-225ClarithromycinClarithromycinAurobindo Pharma LimitedANDACurrent
65862-226ClarithromycinClarithromycinAurobindo Pharma LimitedANDACurrent
65862-226ClarithromycinClarithromycinAurobindo Pharma LimitedANDACurrent
65862-226ClarithromycinClarithromycinAurobindo Pharma LimitedANDACurrent
65862-226ClarithromycinClarithromycinAurobindo Pharma LimitedANDACurrent
65862-226ClarithromycinClarithromycinAurobindo Pharma LimitedANDACurrent
67296-1632ClarithromycinClarithromycinRedPharm Drug, Inc.ANDACurrent
67296-1632ClarithromycinClarithromycinRedPharm Drug, Inc.ANDACurrent
68071-1899ClarithromycinClarithromycinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-5045ClarithromycinClarithromycinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5045ClarithromycinClarithromycinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5045ClarithromycinClarithromycinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5045ClarithromycinClarithromycinNuCare Pharmaceuticals,Inc.ANDACurrent
68788-6936ClarithromycinClarithromycinPreferred Pharmaceuticals Inc.ANDACurrent
68788-6936ClarithromycinClarithromycinPreferred Pharmaceuticals Inc.ANDACurrent
70518-0204ClarithromycinClarithromycinREMEDYREPACK INC.ANDACurrent
70518-0204ClarithromycinClarithromycinREMEDYREPACK INC.ANDACurrent
71335-0017ClarithromycinClarithromycinBryant Ranch PrepackANDACurrent
71335-0017ClarithromycinClarithromycinBryant Ranch PrepackANDACurrent
71335-0017ClarithromycinClarithromycinBryant Ranch PrepackANDACurrent
71335-0017ClarithromycinClarithromycinBryant Ranch PrepackANDACurrent