FDA.reportPublic FDA data

Application 076921

Type
ANDA
Sponsor
AUROBINDO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MIRTAZAPINEMIRTAZAPINETABLET;ORAL7.5MGNoNo
002MIRTAZAPINEMIRTAZAPINETABLET;ORAL15MGNoNo
003MIRTAZAPINEMIRTAZAPINETABLET;ORAL30MGNoNo
004MIRTAZAPINEMIRTAZAPINETABLET;ORAL45MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-7870MirtazapineMirtazapineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8268MirtazapineMirtazapineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8269MirtazapineMirtazapineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
13107-001MirtazapineMirtazapineAurolife Pharma LLCANDACurrent
13107-001MirtazapineMirtazapineAurolife Pharma LLCANDACurrent
13107-001MirtazapineMirtazapineAurolife Pharma LLCANDACurrent
13107-001MirtazapineMirtazapineAurolife Pharma LLCANDACurrent
13107-001MirtazapineMirtazapineAurolife Pharma LLCANDACurrent
13107-003MirtazapineMirtazapineAurolife Pharma LLCANDACurrent
13107-003MirtazapineMirtazapineAurolife Pharma LLCANDACurrent
13107-003MirtazapineMirtazapineAurolife Pharma LLCANDACurrent
13107-003MirtazapineMirtazapineAurolife Pharma LLCANDACurrent
13107-003MirtazapineMirtazapineAurolife Pharma LLCANDACurrent
13107-031MirtazapineMirtazapineAurolife Pharma LLCANDACurrent
13107-031MirtazapineMirtazapineAurolife Pharma LLCANDACurrent
13107-031MirtazapineMirtazapineAurolife Pharma LLCANDACurrent
13107-031MirtazapineMirtazapineAurolife Pharma LLCANDACurrent
13107-031MirtazapineMirtazapineAurolife Pharma LLCANDACurrent
13107-032MirtazapineMirtazapineAurolife Pharma LLCANDACurrent
13107-032MirtazapineMirtazapineAurolife Pharma LLCANDACurrent
13107-032MirtazapineMirtazapineAurolife Pharma LLCANDACurrent
13107-032MirtazapineMirtazapineAurolife Pharma LLCANDACurrent
13107-032MirtazapineMirtazapineAurolife Pharma LLCANDACurrent
17856-0101MirtazapineMirtazapineATLANTIC BIOLOGICALS CORP.ANDACurrent
21695-081MirtazapineMirtazapineRebel Distributors Corp.ANDACurrent
21695-082MirtazapineMirtazapineRebel Distributors Corp.ANDACurrent
21695-083MirtazapineMirtazapineRebel Distributors Corp.ANDACurrent
33261-073MirtazapineMirtazapineAidarex Pharmaceuticals LLCANDACurrent
43353-535MirtazapineMirtazapineAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-535MirtazapineMirtazapineAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-536MirtazapineMirtazapineAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-536MirtazapineMirtazapineAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-614MirtazapineMirtazapineAphena Pharma Solutions - Tennessee, LLCANDACurrent
45865-137MirtazapineMirtazapineMedsource PharmaceuticalsANDACurrent
45865-382MirtazapineMirtazapineMedsource PharmaceuticalsANDACurrent
45865-382MirtazapineMirtazapineMedsource PharmaceuticalsANDACurrent
49999-629MirtazapineMirtazapineLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-629MirtazapineMirtazapineQuality Care Products LLCANDACurrent
49999-629MirtazapineMirtazapineLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-629MirtazapineMirtazapineLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-629MirtazapineMirtazapineLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-629MirtazapineMirtazapineLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-629MirtazapineMirtazapineLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-1057MirtazapineMirtazapineA-S Medication SolutionsANDACurrent
50090-1057MirtazapineMirtazapineA-S Medication SolutionsANDACurrent
50090-2140MirtazapineMirtazapineA-S Medication SolutionsANDACurrent
50090-2558MirtazapineMirtazapineA-S Medication SolutionsANDACurrent
50090-2558MirtazapineMirtazapineA-S Medication SolutionsANDACurrent
50090-2558MirtazapineMirtazapineA-S Medication SolutionsANDACurrent
50090-2800MirtazapineMirtazapineA-S Medication SolutionsANDACurrent
50090-2800MirtazapineMirtazapineA-S Medication SolutionsANDACurrent
50090-2800MirtazapineMirtazapineA-S Medication SolutionsANDACurrent
50090-2800MirtazapineMirtazapineA-S Medication SolutionsANDACurrent
50090-4123MirtazapineMirtazapineA-S Medication SolutionsANDACurrent
50090-4643MirtazapineMirtazapineA-S Medication SolutionsANDACurrent
52959-902MirtazapineMirtazapineH.J. Harkins Company, Inc.ANDACurrent
53002-1474MirtazapineMirtazapineRPK Pharmaceuticals, Inc.ANDACurrent
53002-1474MirtazapineMirtazapineRPK Pharmaceuticals, Inc.ANDACurrent
53002-2712MirtazapineMirtazapineRPK Pharmaceuticals, Inc.ANDACurrent
53808-0646MirtazapineMirtazapineState of Florida DOH Central PharmacyANDACurrent
55154-7141MirtazapineMirtazapineCardinal HealthANDACurrent
55154-7141MirtazapineMirtazapineCardinal HealthANDACurrent
57237-007MirtazapineMirtazapineRising Health, LLCANDACurrent
57237-007MirtazapineMirtazapineRising Health, LLCANDACurrent
57237-007MirtazapineMirtazapineRising Health, LLCANDACurrent
57237-007MirtazapineMirtazapineRising Health, LLCANDACurrent
57237-007MirtazapineMirtazapineRising Health, LLCANDACurrent
57237-007MirtazapineMirtazapineRising Health, LLCANDACurrent
57237-007MirtazapineMirtazapineRising Health, LLCANDACurrent
57237-007MirtazapineMirtazapineRising Health, LLCANDACurrent
57237-008MirtazapineMirtazapineRising Health, LLCANDACurrent
57237-008MirtazapineMirtazapineRising Health, LLCANDACurrent
57237-008MirtazapineMirtazapineRising Health, LLCANDACurrent
57237-008MirtazapineMirtazapineRising Health, LLCANDACurrent
57237-008MirtazapineMirtazapineRising Health, LLCANDACurrent
57237-008MirtazapineMirtazapineRising Health, LLCANDACurrent
57237-008MirtazapineMirtazapineRising Health, LLCANDACurrent
57237-008MirtazapineMirtazapineRising Health, LLCANDACurrent
57237-009MirtazapineMirtazapineRising Health, LLCANDACurrent
57237-009MirtazapineMirtazapineRising Health, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44326ORIG2005-08-01