FDA.reportPublic FDA data

Application 018013

Type
NDA
Sponsor
SPECGX LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PAMELORNORTRIPTYLINE HYDROCHLORIDECAPSULE;ORALEQ 10MG BASEYesNo
002PAMELORNORTRIPTYLINE HYDROCHLORIDECAPSULE;ORALEQ 25MG BASEYesNo
003PAMELORNORTRIPTYLINE HYDROCHLORIDECAPSULE;ORALEQ 75MG BASEYesYes
004PAMELORNORTRIPTYLINE HYDROCHLORIDECAPSULE;ORALEQ 50MG BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0406-9910PAMELORnortriptyline hydrochlorideSpecGx LLCNDACurrent
0406-9910PAMELORnortriptyline hydrochlorideSpecGx LLCNDACurrent
0406-9910PAMELORnortriptyline hydrochlorideSpecGx LLCNDACurrent
0406-9911PAMELORnortriptyline hydrochlorideSpecGx LLCNDACurrent
0406-9911PAMELORnortriptyline hydrochlorideSpecGx LLCNDACurrent
0406-9911PAMELORnortriptyline hydrochlorideSpecGx LLCNDACurrent
0406-9912PAMELORnortriptyline hydrochlorideSpecGx LLCNDACurrent
0406-9912PAMELORnortriptyline hydrochlorideSpecGx LLCNDACurrent
0406-9912PAMELORnortriptyline hydrochlorideSpecGx LLCNDACurrent
0406-9913PAMELORnortriptyline hydrochlorideSpecGx LLCNDACurrent
0406-9913PAMELORnortriptyline hydrochlorideSpecGx LLCNDACurrent
0406-9913PAMELORnortriptyline hydrochlorideSpecGx LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58276SUPPL2019-04-10
58270SUPPL2019-04-10
58269SUPPL2019-04-10
11115SUPPL2014-07-29
779SUPPL2014-07-29
13979SUPPL2014-07-11
11114SUPPL2014-07-11
13978SUPPL2012-10-29
33393SUPPL2012-10-26
23111ORIG2009-11-20
20101SUPPL2009-09-14
778SUPPL2007-07-24
33392SUPPL2007-07-16
23539ORIG2007-05-09
13977SUPPL2005-01-13
11113SUPPL2005-01-13