FDA.reportPublic FDA data

Application 076122

Type
ANDA
Sponsor
MYLAN

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-3515MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3515MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3515MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3515MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3515MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3515MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3515MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3515MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3515MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3530MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3530MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3530MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3530MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3530MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3530MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3530MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3530MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3530MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3545MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3545MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3545MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3545MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3545MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3545MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3545MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3545MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3545MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0615-5527MirtazapineMirtazapineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-5572MirtazapineMirtazapineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-5572MirtazapineMirtazapineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-5573MirtazapineMirtazapineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-5573MirtazapineMirtazapineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
43353-962MirtazapineMirtazapineAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-962MirtazapineMirtazapineAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-963MirtazapineMirtazapineAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-963MirtazapineMirtazapineAphena Pharma Solutions - Tennessee, LLCANDACurrent
51079-086MirtazapineMirtazapineMylan Institutional Inc.ANDACurrent
51079-086MirtazapineMirtazapineMylan Institutional Inc.ANDACurrent
51079-086MirtazapineMirtazapineMylan Institutional Inc.ANDACurrent
51079-087MirtazapineMirtazapineMylan Institutional Inc.ANDACurrent
51079-087MirtazapineMirtazapineMylan Institutional Inc.ANDACurrent
51079-087MirtazapineMirtazapineMylan Institutional Inc.ANDACurrent
51079-088MirtazapineMirtazapineMylan Institutional Inc.ANDACurrent
51079-088MirtazapineMirtazapineMylan Institutional Inc.ANDACurrent
51079-088MirtazapineMirtazapineMylan Institutional Inc.ANDACurrent
51407-350MirtazapineMirtazapineGolden State Medical SupplyANDACurrent
51407-350MirtazapineMirtazapineGolden State Medical SupplyANDACurrent
51407-350MirtazapineMirtazapineGolden State Medical Supply, Inc.ANDACurrent
51407-350MirtazapineMirtazapineGolden State Medical Supply, Inc.ANDACurrent
51407-351MirtazapineMirtazapineGolden State Medical SupplyANDACurrent
51407-351MirtazapineMirtazapineGolden State Medical SupplyANDACurrent
51407-351MirtazapineMirtazapineGolden State Medical Supply, Inc.ANDACurrent
51407-351MirtazapineMirtazapineGolden State Medical Supply, Inc.ANDACurrent
51407-352MirtazapineMirtazapineGolden State Medical Supply, Inc.ANDACurrent
51407-352MirtazapineMirtazapineGolden State Medical Supply, Inc.ANDACurrent
51407-352MirtazapineMirtazapineGolden State Medical SupplyANDACurrent
51407-352MirtazapineMirtazapineGolden State Medical SupplyANDACurrent
53808-0384MirtazapineMirtazapineState of Florida DOH Central PharmacyANDACurrent
55154-5355MirtazapineMirtazapineCardinal HealthANDACurrent
55154-5355MirtazapineMirtazapineCardinal HealthANDACurrent
55154-5355MirtazapineMirtazapineCardinal HealthANDACurrent
55154-5355MirtazapineMirtazapineCardinal HealthANDACurrent
67046-481MirtazapineMirtazapineContract Pharmacy Services-PAANDACurrent
67046-482MirtazapineMirtazapineContract Pharmacy Services-PAANDACurrent
67046-483MirtazapineMirtazapineContract Pharmacy Services-PAANDACurrent
70518-0102MirtazapineMirtazapineREMEDYREPACK INC.ANDACurrent
70518-0102MirtazapineMirtazapineREMEDYREPACK INC.ANDACurrent
70518-0102MirtazapineMirtazapineREMEDYREPACK INC.ANDACurrent
71610-475MirtazapineMirtazapineAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-523MirtazapineMirtazapineAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-523MirtazapineMirtazapineAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-523MirtazapineMirtazapineAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44287ORIG2005-08-01
43054ORIG2005-07-22
31081ORIG2003-04-10