FDA.reportPublic FDA data

Application 202632

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDETABLET;ORALEQ 400MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50268-576Moxifloxacin HydrochlorideMoxifloxacin HydrochlorideAvPAKANDACurrent
50268-576Moxifloxacin HydrochlorideMoxifloxacin HydrochlorideAvPAKANDACurrent
50268-576Moxifloxacin HydrochlorideMoxifloxacin HydrochlorideAvPAKANDACurrent
57237-156Moxifloxacin HydrochlorideMoxifloxacin HydrochlorideRising Health, LLCANDACurrent
57237-156Moxifloxacin HydrochlorideMoxifloxacin HydrochlorideRising Health, LLCANDACurrent
57237-156Moxifloxacin HydrochlorideMoxifloxacin HydrochlorideRising Health, LLCANDACurrent
57237-156Moxifloxacin HydrochlorideMoxifloxacin HydrochlorideRising Health, LLCANDACurrent
57237-156Moxifloxacin HydrochlorideMoxifloxacin HydrochlorideRising Health, LLCANDACurrent
65862-603MOXIFLOXACIN HYDROCHLORIDEmoxifloxacin hydrochlorideAurobindo Pharma LimitedANDACurrent
65862-603MOXIFLOXACIN HYDROCHLORIDEmoxifloxacin hydrochlorideAurobindo Pharma LimitedANDACurrent
65862-603MOXIFLOXACIN HYDROCHLORIDEmoxifloxacin hydrochlorideAurobindo Pharma LimitedANDACurrent
65862-603MOXIFLOXACIN HYDROCHLORIDEmoxifloxacin hydrochlorideAurobindo Pharma LimitedANDACurrent
65862-603MOXIFLOXACIN HYDROCHLORIDEmoxifloxacin hydrochlorideAurobindo Pharma LimitedANDACurrent
67296-1616Moxifloxacin HydrochlorideMoxifloxacin HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1616Moxifloxacin HydrochlorideMoxifloxacin HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1616Moxifloxacin HydrochlorideMoxifloxacin HydrochlorideRedPharm Drug, Inc.ANDACurrent
68084-722Moxifloxacin HydrochlorideMoxifloxacin HydrochlorideAmerican Health PackagingANDACurrent
68084-722Moxifloxacin HydrochlorideMoxifloxacin HydrochlorideAmerican Health PackagingANDACurrent
68084-722Moxifloxacin HydrochlorideMoxifloxacin HydrochlorideAmerican Health PackagingANDACurrent
68084-722Moxifloxacin HydrochlorideMoxifloxacin HydrochlorideAmerican Health PackagingANDACurrent
68084-722Moxifloxacin HydrochlorideMoxifloxacin HydrochlorideAmerican Health PackagingANDACurrent
72789-037MOXIFLOXACIN HYDROCHLORIDEmoxifloxacin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-037MOXIFLOXACIN HYDROCHLORIDEmoxifloxacin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-037MOXIFLOXACIN HYDROCHLORIDEmoxifloxacin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-037MOXIFLOXACIN HYDROCHLORIDEmoxifloxacin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-038MOXIFLOXACIN HYDROCHLORIDEmoxifloxacin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-038MOXIFLOXACIN HYDROCHLORIDEmoxifloxacin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-038MOXIFLOXACIN HYDROCHLORIDEmoxifloxacin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-038MOXIFLOXACIN HYDROCHLORIDEmoxifloxacin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10088ORIG2014-03-06