FDA.reportPublic FDA data

Application 020415

Type
NDA
Sponsor
ORGANON USA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001REMERONMIRTAZAPINETABLET;ORAL15MGYesYes
002REMERONMIRTAZAPINETABLET;ORAL30MGYesNo
003REMERONMIRTAZAPINETABLET;ORAL45MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0052-0105REMERONMIRTAZAPINEOrganon USA Inc.NDACurrent
0052-0105REMERONMIRTAZAPINEOrganon USA Inc.NDACurrent
0052-0105REMERONMIRTAZAPINEOrganon USA Inc.NDACurrent
0052-0105REMERONMIRTAZAPINEOrganon USA Inc.NDACurrent
0052-0105REMERONMIRTAZAPINEOrganon USA Inc.NDACurrent
0052-0107REMERONMIRTAZAPINEOrganon USA Inc.NDACurrent
0052-0107REMERONMIRTAZAPINEOrganon USA Inc.NDACurrent
0052-0107REMERONMIRTAZAPINEOrganon USA Inc.NDACurrent
0052-0107REMERONMIRTAZAPINEOrganon USA Inc.NDACurrent
0052-0107REMERONMIRTAZAPINEOrganon USA Inc.NDACurrent
0052-0109REMERONMIRTAZAPINEOrganon USA Inc.NDACurrent
0052-0109REMERONMIRTAZAPINEOrganon USA Inc.NDACurrent
0052-4364REMERONMIRTAZAPINEOrganon USA Inc.NDACurrent
0052-4364REMERONMIRTAZAPINEOrganon USA Inc.NDACurrent
0052-4364REMERONMIRTAZAPINEOrganon USA Inc.NDACurrent
0052-4364REMERONMIRTAZAPINEOrganon USA Inc.NDACurrent
0052-4364REMERONMIRTAZAPINEOrganon USA Inc.NDACurrent
0052-4365REMERONMIRTAZAPINEOrganon USA Inc.NDACurrent
0052-4365REMERONMIRTAZAPINEOrganon USA Inc.NDACurrent
0052-4365REMERONMIRTAZAPINEOrganon USA Inc.NDACurrent
0052-4365REMERONMIRTAZAPINEOrganon USA Inc.NDACurrent
0052-4365REMERONMIRTAZAPINEOrganon USA Inc.NDACurrent
70518-0903REMERONMIRTAZAPINEREMEDYREPACK INC.NDACurrent
70518-0903REMERONMIRTAZAPINEREMEDYREPACK INC.NDACurrent
70518-2176REMERONMIRTAZAPINEREMEDYREPACK INC.NDACurrent
70518-2176REMERONMIRTAZAPINEREMEDYREPACK INC.NDACurrent
78206-160REMERONMIRTAZAPINEOrganon LLCNDACurrent
78206-160REMERONMIRTAZAPINEOrganon LLCNDACurrent
78206-160REMERONMIRTAZAPINEOrganon LLCNDACurrent
78206-161REMERONMIRTAZAPINEOrganon LLCNDACurrent
78206-161REMERONMIRTAZAPINEOrganon LLCNDACurrent
78206-161REMERONMIRTAZAPINEOrganon LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85991SUPPL 2026-05-21
85987SUPPL 2026-05-21
69360SUPPL2021-11-19
69359SUPPL2021-11-19
62779SUPPL2020-04-30
62778SUPPL2020-04-30
62777SUPPL2020-04-30
62776SUPPL2020-04-30
62763SUPPL2020-04-30
62762SUPPL2020-04-30
62034SUPPL2020-03-04
62033SUPPL2020-03-04
59931SUPPL2019-09-06
59926SUPPL2019-09-06
59923SUPPL2019-09-06
12570SUPPL2016-08-01
12572SUPPL2015-12-31
2529SUPPL2015-12-31
12571SUPPL2014-07-30
24952SUPPL2014-07-23
23157SUPPL2012-11-06
12569SUPPL2012-11-06
2528SUPPL2012-11-01
24950SUPPL2011-12-29
34640SUPPL2011-12-27
12568SUPPL2010-05-28
12567SUPPL2010-05-28
24951SUPPL2010-05-21
2527SUPPL2010-05-21
2526SUPPL2007-08-02
34639SUPPL2007-07-31
44057ORIG2005-08-01
12566SUPPL2005-01-13
2525SUPPL2005-01-13
41354SUPPL2004-09-08
2524SUPPL2004-06-07
2523SUPPL2002-10-02
24949SUPPL2002-04-16
57465ORIG1996-06-14