Hydrochlorothiazide / Metoprolol Extended Release Oral Tablet

Brand(s)
Dutoprol
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Concordia Pharmaceuticals Inc. (2015-08-06)
Oldest Current Product
2011-09-16
License(s)
NDA
RxNORM
EXTENDED RELEASE ORAL TABLET\HYDROCHLOROTHIAZIDE:METOPROLOL
FDAOB
ORAL\TABLET, EXTENDED RELEASE\HYDROCHLOROTHIAZIDE: METOPROLOL SUCCINATE
SPL Active
ORAL\TABLET, FILM COATED\HYDROCHLOROTHIAZIDE: METOPROLOL SUCCINATE
ORAL\TABLET\HYDROCHLOROTHIAZIDE: METOPROLOL SUCCINATE
SPL Moiety
ORAL\TABLET, FILM COATED\HYDROCHLOROTHIAZIDE: METOPROLOL
ORAL\TABLET\HYDROCHLOROTHIAZIDE: METOPROLOL

product(s) by strength(s)

24 hr hydrochlorothiazide 12.5 mg / metoprolol succinate 100 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003101097DutoprolNDAAstrazeneca Pharmaceuticals Lp2011-12-30HYDROCHLOROTHIAZIDE, METOPROLOL SUCCINATEORALTABLET, FILM COATEDNDA02195623ab5537-5d5b-41d6-618c-974930319a48
2592120097DutoprolNDAConcordia Pharmaceuticals Inc.2014-07-01HYDROCHLOROTHIAZIDE, METOPROLOL SUCCINATEORALTABLETNDA02195669ffe86d-7993-482d-b1bb-04287bdd6aa9

24 hr hydrochlorothiazide 12.5 mg / metoprolol succinate 25 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001861087DutoprolNDAAstrazeneca Lp2011-09-16HYDROCHLOROTHIAZIDE, METOPROLOL SUCCINATEORALTABLET, FILM COATEDNDA0219562f5143ca-e796-4add-63a4-90a58913f624
2592120087DutoprolNDAConcordia Pharmaceuticals Inc.2014-07-01HYDROCHLOROTHIAZIDE, METOPROLOL SUCCINATEORALTABLETNDA02195669ffe86d-7993-482d-b1bb-04287bdd6aa9

24 hr hydrochlorothiazide 12.5 mg / metoprolol succinate 50 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001861095DutoprolNDAAstrazeneca Lp2011-09-16HYDROCHLOROTHIAZIDE, METOPROLOL SUCCINATEORALTABLET, FILM COATEDNDA0219562f5143ca-e796-4add-63a4-90a58913f624
2592120095DutoprolNDAConcordia Pharmaceuticals Inc.2014-07-01HYDROCHLOROTHIAZIDE, METOPROLOL SUCCINATEORALTABLETNDA02195669ffe86d-7993-482d-b1bb-04287bdd6aa9

application(s)

#idtitleapplicantapprovedapproved drug
1NDA021956DUTOPROLCONCORDIA PHARMACEUTICALS INC2006-08-28NDA021956_001, NDA021956_002, NDA021956_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA021956_001RXHYDROCHLOROTHIAZIDE (12.5MG), METOPROLOL SUCCINATE (EQ 25MG TARTRATE)ORALTABLET, EXTENDED RELEASEFalse2006-08-28DUTOPROL
2NDA021956_002RXHYDROCHLOROTHIAZIDE (12.5MG), METOPROLOL SUCCINATE (EQ 50MG TARTRATE)ORALTABLET, EXTENDED RELEASEFalse2006-08-28DUTOPROL
3NDA021956_003RXHYDROCHLOROTHIAZIDE (12.5MG), METOPROLOL SUCCINATE (EQ 100MG TARTRATE)ORALTABLET, EXTENDED RELEASETrue2006-08-28DUTOPROL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
123ab5537-5d5b-41d6-618c-974930319a48 (view SPL)DUTOPROL (metoprolol succinate extended release/hydrochlorothiazide) TabletprescriptionHuman PrescriptionAstrazeneca Pharmaceuticals Lp2011-12-193003101097, 003101087, 003101095
22f5143ca-e796-4add-63a4-90a58913f624 (view SPL)DUTOPROL(metoprolol succinate extended release/hydrochlorothiazide)Tablet, Film CoatedprescriptionHuman PrescriptionAstrazeneca LpAPI MANUFACTURE, MANUFACTURE2011-02-089001861087, 001861095, 001861097
354f5dfe4-886a-446a-a972-8080ed903b0b (view SPL)These highlights do not include all the information needed to use DUTOPROL safely and effectively. See full prescribing information for DUTOPROL. DUTOPROL (metoprolol succinate extended release/hydrochlorothiazide) tablets, for oral useInitial U.S. Approval: 2006prescriptionHuman PrescriptionCovis Pharmaceuticals, Inc.2014-10-312249870087, 249870095, 249870097
469ffe86d-7993-482d-b1bb-04287bdd6aa9 (view SPL)These highlights do not include all the information needed to use DUTOPROL safely and effectively. See full prescribing information for DUTOPROL. DUTOPROL (metoprolol succinate extended release/hydrochlorothiazide) tablets, for oral useInitial U.S. Approval: 2006prescriptionHuman PrescriptionConcordia Pharmaceuticals Inc.api manufacture2015-08-061592120087, 592120095, 592120097

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