FDA.reportPublic FDA data

Application 208156

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDESPRAY, METERED;NASALEQ 0.125MG BASE/SPRAYNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67877-477AzelastineAzelastineAscend Laboratories, LLCANDACurrent
67877-477AzelastineAzelastineAscend Laboratories, LLCANDACurrent
67877-477AzelastineAzelastineAscend Laboratories, LLCANDACurrent
67877-477AzelastineAzelastineAscend Laboratories, LLCANDACurrent