FDA.reportPublic FDA data

Application 205798

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MIRTAZAPINEMIRTAZAPINETABLET, ORALLY DISINTEGRATING;ORAL15MGNoNo
002MIRTAZAPINEMIRTAZAPINETABLET, ORALLY DISINTEGRATING;ORAL30MGNoNo
003MIRTAZAPINEMIRTAZAPINETABLET, ORALLY DISINTEGRATING;ORAL45MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-676mirtazapinemirtazapineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-676mirtazapinemirtazapineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-676mirtazapinemirtazapineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-676mirtazapinemirtazapineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-676mirtazapinemirtazapineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-677mirtazapinemirtazapineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-677mirtazapinemirtazapineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-677mirtazapinemirtazapineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-677mirtazapinemirtazapineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-677mirtazapinemirtazapineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-679mirtazapinemirtazapineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-679mirtazapinemirtazapineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-679mirtazapinemirtazapineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-679mirtazapinemirtazapineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-679mirtazapinemirtazapineZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1072mirtazapinemirtazapineCadila Healthcare LimitedANDACurrent
70771-1072mirtazapinemirtazapineCadila Healthcare LimitedANDACurrent
70771-1072mirtazapinemirtazapineCadila Healthcare LimitedANDACurrent
70771-1072mirtazapinemirtazapineCadila Healthcare LimitedANDACurrent
70771-1073mirtazapinemirtazapineCadila Healthcare LimitedANDACurrent
70771-1073mirtazapinemirtazapineCadila Healthcare LimitedANDACurrent
70771-1073mirtazapinemirtazapineCadila Healthcare LimitedANDACurrent
70771-1073mirtazapinemirtazapineCadila Healthcare LimitedANDACurrent
70771-1074mirtazapinemirtazapineCadila Healthcare LimitedANDACurrent
70771-1074mirtazapinemirtazapineCadila Healthcare LimitedANDACurrent
70771-1074mirtazapinemirtazapineCadila Healthcare LimitedANDACurrent
70771-1074mirtazapinemirtazapineCadila Healthcare LimitedANDACurrent
72578-103MirtazapineMirtazapineViona Pharmaceuticals Inc.ANDACurrent
72578-104MirtazapineMirtazapineViona Pharmaceuticals Inc.ANDACurrent
72578-105MirtazapineMirtazapineViona Pharmaceuticals Inc.ANDACurrent
76483-110MirtazapineMirtazapineSQUARE PHARMACEUTICALS LIMITEDANDACurrent
76483-111MirtazapineMirtazapineSQUARE PHARMACEUTICALS LIMITEDANDACurrent
76483-112MirtazapineMirtazapineSQUARE PHARMACEUTICALS LIMITEDANDACurrent