FDA.reportPublic FDA data

Application 207411

Type
ANDA
Sponsor
SOMERSET THERAPS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDESOLUTION/DROPS;OPHTHALMIC0.05%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70069-091Azelastine HydrochlorideAzelastine HydrochlorideSomerset Therapeutics, LLCANDACurrent
70069-091Azelastine HydrochlorideAzelastine HydrochlorideSomerset Therapeutics, LLCANDACurrent
70069-091Azelastine HydrochlorideAzelastine HydrochlorideSomerset Therapeutics, LLCANDACurrent