Sertraline Oral Solution

Brand(s)
Zoloft
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Greenstone Llc (2015-04-28)
Oldest Current Product
1992-02-11
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL SOLUTION\SERTRALINE
FDAOB
ORAL\CONCENTRATE\SERTRALINE HYDROCHLORIDE
SPL Active
ORAL\SOLUTION, CONCENTRATE\SERTRALINE HYDROCHLORIDE
ORAL\SOLUTION\SERTRALINE HYDROCHLORIDE
SPL Moiety
ORAL\SOLUTION, CONCENTRATE\SERTRALINE
ORAL\SOLUTION\SERTRALINE

product(s) by strength(s)

sertraline 20 mg/ml oral solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000494940ZoloftNDARoerig1992-02-11SERTRALINE HYDROCHLORIDEORALSOLUTION, CONCENTRATENDA020990fe9e8b7d-61ea-409d-84aa-3ebd79a046b5

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1167140601ANDANorthstar Rx Llc2008-10-31SERTRALINE HYDROCHLORIDEORALSOLUTIONANDA0788617f144b68-ae90-483c-b030-f6824662a734
2597624940NDA AUTHORIZED GENERICGreenstone Llc1992-02-11SERTRALINE HYDROCHLORIDEORALSOLUTION, CONCENTRATENDA0209901a58062b-e635-431a-908d-2651c6a4a21c
3658620224ANDAAurobindo Pharma Limited2008-10-31SERTRALINE HYDROCHLORIDEORALSOLUTION, CONCENTRATEANDA07886101800452-c353-4235-a66a-214048752e74

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drug
1ANDA076934SERTRALINE HYDROCHLORIDETrueROXANE LABORATORIES INC2006-06-30ANDA076934_001
2ANDA078053SERTRALINE HYDROCHLORIDETrueRANBAXY LABORATORIES LTD2007-02-05ANDA078053_001
3ANDA078861SERTRALINE HYDROCHLORIDEAUROBINDO PHARMA LTD2008-10-31ANDA078861_001
4NDA020990ZOLOFTPFIZER PHARMACEUTICALS INC1999-12-07p7067555, SUBSTANCE
p6727283, TREATMENT OF DISORDERS OF THE SEROTONERGIC SYSTEM SUCH AS DEPRESSION AND ANXIETY-RELATED DISORDERS, SUBSTANCE
NDA020990_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076934_001discontinuedSERTRALINE HYDROCHLORIDE (EQ 20MG BASE/ML)ORALCONCENTRATEFalse2006-06-30SERTRALINE HYDROCHLORIDE
2ANDA078053_001discontinuedSERTRALINE HYDROCHLORIDE (EQ 20MG BASE/ML)ORALCONCENTRATEFalse2007-02-05SERTRALINE HYDROCHLORIDE
3ANDA078861_001RXSERTRALINE HYDROCHLORIDE (EQ 20MG BASE/ML)ORALCONCENTRATEFalseAA2008-10-31SERTRALINE HYDROCHLORIDE
4NDA020990_001RXSERTRALINE HYDROCHLORIDE (EQ 20MG BASE/ML)ORALCONCENTRATETrueAA1999-12-07ZOLOFT

patent(s)

#idexpiration dateapplication(s)
1p6727283 (view patent)2019-10-11NDA020990
2p7067555 (view patent)2019-10-11NDA020990

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
101800452-c353-4235-a66a-214048752e74 (view SPL)Sertraline Hydrochloride Oral Solution USPRx onlyprescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2014-10-1015658620224
21a58062b-e635-431a-908d-2651c6a4a21c (view SPL)SERTRALINE HYDROCHLORIDE Tablets and Oral ConcentrateprescriptionHuman PrescriptionGreenstone LlcAPI MANUFACTURE, MANUFACTURE, PACK2015-04-2824597624940, 597624900, 597624910, 597624960Sertraline Oral Tablet
37f144b68-ae90-483c-b030-f6824662a734 (view SPL)Sertraline Hydrochloride Oral Solution USPRx onlyprescriptionHuman PrescriptionNorthstar Rx LlcANALYSIS, API MANUFACTURE, MANUFACTURE2014-12-046167140601
4fe9e8b7d-61ea-409d-84aa-3ebd79a046b5 (view SPL)ZOLOFT (sertraline hydrochloride)Tablets and Oral ConcentrateprescriptionHuman PrescriptionRoerigAPI MANUFACTURE, MANUFACTURE, PACK2014-08-2632000494940, 000494900, 000494910, 000494960Sertraline Oral Tablet

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