FDA.reportPublic FDA data

Application 065197

Type
ANDA
Sponsor
WOCKHARDT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFOTAXIMECEFOTAXIME SODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIALNoNo
002CEFOTAXIME SODIUMCEFOTAXIME SODIUMINJECTABLE;INJECTIONEQ 500MG BASE/VIALNoNo
003CEFOTAXIME SODIUMCEFOTAXIME SODIUMINJECTABLE;INJECTIONEQ 2GM BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55648-947CEFOTAXIMECEFOTAXIMEWOCKHARDT LIMITEDANDACurrent
55648-948CEFOTAXIMECEFOTAXIMEWOCKHARDT LIMITEDANDACurrent
55648-986CEFOTAXIMECEFOTAXIMEWOCKHARDT LIMITEDANDACurrent
64679-947CefotaximeCefotaximeWockhardt USA LLC.ANDACurrent
64679-947CefotaximeCefotaximeWockhardt USA LLC.ANDACurrent
64679-948CefotaximeCefotaximeWockhardt USA LLC.ANDACurrent
64679-948CefotaximeCefotaximeWockhardt USA LLC.ANDACurrent
64679-986CefotaximeCefotaximeWockhardt USA LLC.ANDACurrent
64679-986CefotaximeCefotaximeWockhardt USA LLC.ANDACurrent