FDA.reportPublic FDA data

Application 065501

Type
ANDA
Sponsor
GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZITHROMYCINAZITHROMYCININJECTABLE;INJECTIONEQ 500MG BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60505-6076Azithromycinazithromycin for injection injection, powder, lyophilized, for solutionAPOTEX CORP.ANDACurrent
60505-6076Azithromycinazithromycin for injection injection, powder, lyophilized, for solutionAPOTEX CORP.ANDACurrent
68083-199Azithromycin monohydrateAzithromycin monohydrateGland Pharma LimitedANDACurrent
68083-199Azithromycin monohydrateAzithromycin monohydrateGland Pharma LimitedANDACurrent
68083-199Azithromycin monohydrateAzithromycin monohydrateGland Pharma LimitedANDACurrent
70860-100Azithromycinazithromycin monohydrateAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-100Azithromycinazithromycin monohydrateAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-100Azithromycinazithromycin monohydrateAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-100Azithromycinazithromycin monohydrateAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-100Azithromycinazithromycin monohydrateAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-125Azithromycinazithromycin monohydrateAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-125Azithromycinazithromycin monohydrateAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-125Azithromycinazithromycin monohydrateAthenex Pharmaceutical Division, LLC.ANDACurrent