FDA.reportPublic FDA data

Application 065488

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZITHROMYCINAZITHROMYCINFOR SUSPENSION;ORALEQ 100MG BASE/5MLNoNo
002AZITHROMYCINAZITHROMYCINFOR SUSPENSION;ORALEQ 200MG BASE/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43386-470AzithromycinAzithromycinLupin Pharmaceuticals,Inc.ANDACurrent
43386-470AzithromycinAzithromycinLupin Pharmaceuticals,Inc.ANDACurrent
43386-471AzithromycinAzithromycinLupin Pharmaceuticals,Inc.ANDACurrent
43386-471AzithromycinAzithromycinLupin Pharmaceuticals,Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57399SUPPL2019-02-01
57398SUPPL2019-02-01