Nortriptyline Oral Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pharmaceutical Associates, Inc. (2012-07-17)
Oldest Current Product
2000-08-23
License(s)
ANDA
RxNORM
ORAL SOLUTION\NORTRIPTYLINE
FDAOB
ORAL\SOLUTION\NORTRIPTYLINE HYDROCHLORIDE
SPL Active
ORAL\SOLUTION\NORTRIPTYLINE HYDROCHLORIDE
SPL Moiety
ORAL\SOLUTION\NORTRIPTYLINE

product(s) by strength(s)

nortriptyline 2 mg/ml oral solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001210678ANDAPharmaceutical Associates, Inc.2000-08-23NORTRIPTYLINE HYDROCHLORIDEORALSOLUTIONANDA0756063fcabf90-357a-4a06-b680-9572dc28bcfe

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA075606NORTRIPTYLINE HYDROCHLORIDEPHARMACEUTICAL ASSOC INC2000-08-28ANDA075606_001
2ANDA077965NORTRIPTYLINE HYDROCHLORIDETARO PHARMACEUTICAL INDUSTRIES LTD2006-06-20ANDA077965_001
3NDA014685AVENTYL TrueRANBAXY PHARMACEUTICALS INCNDA014685_001
4NDA018012PAMELORTrueMALLINCKRODT INCNDA018012_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA075606_001RXNORTRIPTYLINE HYDROCHLORIDE (EQ 10MG BASE/5ML)ORALSOLUTIONTrueAA2000-08-28NORTRIPTYLINE HYDROCHLORIDE
2ANDA077965_001RXNORTRIPTYLINE HYDROCHLORIDE (EQ 10MG BASE/5ML)ORALSOLUTIONFalseAA2006-06-20NORTRIPTYLINE HYDROCHLORIDE
3NDA014685_001discontinuedNORTRIPTYLINE HYDROCHLORIDE (EQ 10MG BASE/5ML)ORALSOLUTIONFalseAVENTYL
4NDA018012_001discontinuedNORTRIPTYLINE HYDROCHLORIDE (EQ 10MG BASE/5ML)ORALSOLUTIONFalsePAMELOR

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
13fcabf90-357a-4a06-b680-9572dc28bcfe (view SPL)Nortriptyline Hydrochloride Oral Solution USPprescriptionHuman PrescriptionPharmaceutical Associates, Inc.Manufacture2012-07-173001210678

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII