FDA.reportPublic FDA data

Application 204660

Type
ANDA
Sponsor
AMNEAL PHARMS LLC

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
42291-094Azelastine HydrochlorideAzelastineAvKAREANDACurrent
42291-094Azelastine HydrochlorideAzelastineAvKAREANDACurrent
50090-3833Azelastine HydrochlorideAzelastineA-S Medication SolutionsANDACurrent
50090-3833Azelastine HydrochlorideAzelastineA-S Medication SolutionsANDACurrent
50090-3833Azelastine HydrochlorideAzelastineA-S Medication SolutionsANDACurrent
65162-676Azelastine HydrochlorideAzelastineAmneal Pharmaceuticals LLCANDACurrent
65162-676Azelastine HydrochlorideAzelastineAmneal Pharmaceuticals LLCANDACurrent
65162-676Azelastine HydrochlorideAzelastineAmneal Pharmaceuticals LLCANDACurrent
65162-676Azelastine HydrochlorideAzelastineAmneal Pharmaceuticals LLCANDACurrent