FDA.reportPublic FDA data

Application 021208

Type
NDA
Sponsor
ORGANON USA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001REMERON SOLTABMIRTAZAPINETABLET, ORALLY DISINTEGRATING;ORAL15MGYesYes
002REMERON SOLTABMIRTAZAPINETABLET, ORALLY DISINTEGRATING;ORAL30MGYesNo
003REMERON SOLTABMIRTAZAPINETABLET, ORALLY DISINTEGRATING;ORAL45MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0052-0106REMERONSOLTABMIRTAZAPINEOrganon USA Inc.NDACurrent
0052-0106REMERONSOLTABMIRTAZAPINEOrganon USA Inc.NDACurrent
0052-0106REMERONSOLTABMIRTAZAPINEOrganon USA Inc.NDACurrent
0052-0106REMERONSOLTABMIRTAZAPINEOrganon USA Inc.NDACurrent
0052-0106REMERONSOLTABMIRTAZAPINEOrganon USA Inc.NDACurrent
0052-0108REMERONSOLTABMIRTAZAPINEOrganon USA Inc.NDACurrent
0052-0108REMERONSOLTABMIRTAZAPINEOrganon USA Inc.NDACurrent
0052-0108REMERONSOLTABMIRTAZAPINEOrganon USA Inc.NDACurrent
0052-0108REMERONSOLTABMIRTAZAPINEOrganon USA Inc.NDACurrent
0052-0108REMERONSOLTABMIRTAZAPINEOrganon USA Inc.NDACurrent
0052-0110REMERONSOLTABMIRTAZAPINEOrganon USA Inc.NDACurrent
0052-0110REMERONSOLTABMIRTAZAPINEOrganon USA Inc.NDACurrent
0052-0110REMERONSOLTABMIRTAZAPINEOrganon USA Inc.NDACurrent
0052-0110REMERONSOLTABMIRTAZAPINEOrganon USA Inc.NDACurrent
0052-0110REMERONSOLTABMIRTAZAPINEOrganon USA Inc.NDACurrent
78206-156REMERONSOLTABMIRTAZAPINEOrganon LLCNDACurrent
78206-156REMERONSOLTABMIRTAZAPINEOrganon LLCNDACurrent
78206-156REMERONSOLTABMIRTAZAPINEOrganon LLCNDACurrent
78206-158REMERONSOLTABMIRTAZAPINEOrganon LLCNDACurrent
78206-158REMERONSOLTABMIRTAZAPINEOrganon LLCNDACurrent
78206-158REMERONSOLTABMIRTAZAPINEOrganon LLCNDACurrent
78206-159REMERONSOLTABMIRTAZAPINEOrganon LLCNDACurrent
78206-159REMERONSOLTABMIRTAZAPINEOrganon LLCNDACurrent
78206-159REMERONSOLTABMIRTAZAPINEOrganon LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69362SUPPL2021-11-19
69361SUPPL2021-11-19
62783SUPPL2020-04-30
62782SUPPL2020-04-30
62781SUPPL2020-04-30
62780SUPPL2020-04-30
62766SUPPL2020-04-30
62765SUPPL2020-04-30
62764SUPPL2020-04-30
62037SUPPL2020-03-04
62035SUPPL2020-03-04
59932SUPPL2019-09-06
59925SUPPL2019-09-06
59924SUPPL2019-09-06
14636SUPPL2016-08-01
14637SUPPL2015-12-31
4643SUPPL2015-12-31
36359SUPPL2014-07-30
27073SUPPL2014-07-23
36358SUPPL2012-11-06
4642SUPPL2012-11-01
36356SUPPL2012-01-26
27071SUPPL2012-01-03
36357SUPPL2010-05-28
14635SUPPL2010-05-28
27072SUPPL2010-05-21
4641SUPPL2010-05-21
4640SUPPL2007-08-02
36355SUPPL2007-07-31
23633ORIG2005-08-01
27070SUPPL2005-01-13
14634SUPPL2005-01-13
27069SUPPL2004-06-07
27068SUPPL2003-07-24
21507ORIG2002-04-29
27067ORIG2001-01-12
14633ORIG2001-01-12