FDA.reportPublic FDA data

Application 076119

Type
ANDA
Sponsor
TEVA

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
0093-7206MirtazapineMirtazapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7206MirtazapineMirtazapineTeva Pharmaceuticals USA,ANDACurrent
0093-7207MirtazapineMirtazapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7207MirtazapineMirtazapineTeva Pharmaceuticals USA,ANDACurrent
0093-7208MirtazapineMirtazapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7208MirtazapineMirtazapineTeva Pharmaceuticals USA,ANDACurrent
43063-674MirtazapineMirtazapinePD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-3083MirtazapineMirtazapineA-S Medication SolutionsANDACurrent
63187-207MirtazapineMirtazapineProficient Rx LPANDACurrent
63739-355MirtazapineMirtazapineMcKesson CorporationANDACurrent
63739-356MirtazapineMirtazapineMcKesson CorporationANDACurrent
70518-0901MirtazapineMirtazapineREMEDYREPACK INC.ANDACurrent
70518-0901MirtazapineMirtazapineREMEDYREPACK INC.ANDACurrent
70518-0977MirtazapineMirtazapineREMEDYREPACK INC.ANDACurrent
70518-0977MirtazapineMirtazapineREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23802ORIG2005-08-01
43053ORIG2005-07-22
31079ORIG2004-06-24