Application 021956

Type: NDA
Sponsor: CONCORDIA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DUTOPROL	HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE	TABLET, EXTENDED RELEASE;ORAL	12.5MG;EQ 25MG TARTRATE	Yes	No
002	DUTOPROL	HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE	TABLET, EXTENDED RELEASE;ORAL	12.5MG;EQ 50MG TARTRATE	Yes	No
003	DUTOPROL	HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE	TABLET, EXTENDED RELEASE;ORAL	12.5MG;EQ 100MG TARTRATE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N021956-001	DUTOPROL	HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE	12.5MG;EQ 25MG TARTRATE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-08-28
N021956-002	DUTOPROL	HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE	12.5MG;EQ 50MG TARTRATE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-08-28
N021956-003	DUTOPROL	HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE	12.5MG;EQ 100MG TARTRATE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-08-28

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021956-002	DUTOPROL	12.5MG;EQ 50MG TARTRATE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-08-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021956-003	DUTOPROL	12.5MG;EQ 100MG TARTRATE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021956-001	DUTOPROL	12.5MG;EQ 25MG TARTRATE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-08-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021956-002	DUTOPROL	12.5MG;EQ 50MG TARTRATE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-08-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021956-003	DUTOPROL	12.5MG;EQ 100MG TARTRATE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021956-001	DUTOPROL	12.5MG;EQ 25MG TARTRATE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-08-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021956-002	DUTOPROL	12.5MG;EQ 50MG TARTRATE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-08-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021956-003	DUTOPROL	12.5MG;EQ 100MG TARTRATE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-08-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021956-001	DUTOPROL	12.5MG;EQ 25MG TARTRATE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-08-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021956-002	DUTOPROL	12.5MG;EQ 50MG TARTRATE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-08-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021956-003	DUTOPROL	12.5MG;EQ 100MG TARTRATE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-08-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021956-001	DUTOPROL	12.5MG;EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-08-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021956-002	DUTOPROL	12.5MG;EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-08-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021956-003	DUTOPROL	12.5MG;EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-08-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021956-001	DUTOPROL	12.5MG;EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-08-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021956-002	DUTOPROL	12.5MG;EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-08-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021956-003	DUTOPROL	12.5MG;EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-08-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021956-001	DUTOPROL	12.5MG;EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-08-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021956-002	DUTOPROL	12.5MG;EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-08-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021956-003	DUTOPROL	12.5MG;EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-08-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021956-001	DUTOPROL	12.5MG;EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-08-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021956-002	DUTOPROL	12.5MG;EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-08-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021956-003	DUTOPROL	12.5MG;EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-08-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021956-001	DUTOPROL	12.5MG;EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-08-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021956-002	DUTOPROL	12.5MG;EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-08-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021956-003	DUTOPROL	12.5MG;EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-08-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021956-001	DUTOPROL	12.5MG;EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-08-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021956-002	DUTOPROL	12.5MG;EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-08-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021956-003	DUTOPROL	12.5MG;EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-08-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021956-001	DUTOPROL	12.5MG;EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-08-28	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021956-002	DUTOPROL	12.5MG;EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-08-28	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021956-003	DUTOPROL	12.5MG;EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-08-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021956-001	DUTOPROL	12.5MG;EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-08-28	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021956-002	DUTOPROL	12.5MG;EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-08-28	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021956-003	DUTOPROL	12.5MG;EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-08-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021956-001	DUTOPROL	12.5MG;EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-08-28	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021956-002	DUTOPROL	12.5MG;EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-08-28	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021956-003	DUTOPROL	12.5MG;EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-08-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021956-001	DUTOPROL	12.5MG;EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-08-28	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021956-002	DUTOPROL	12.5MG;EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-08-28	`c0c555d07b60…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59212-087	Dutoprol	metoprolol succinate and hydrochlorothiazide	Concordia Pharmaceuticals Inc.	NDA	Current
59212-087	Dutoprol	metoprolol succinate and hydrochlorothiazide	Concordia Pharmaceuticals Inc.	NDA	Current
59212-087	Dutoprol	metoprolol succinate and hydrochlorothiazide	Concordia Pharmaceuticals Inc.	NDA	Current
59212-087	Dutoprol	metoprolol succinate and hydrochlorothiazide	Concordia Pharmaceuticals Inc.	NDA	Current
59212-087	Dutoprol	metoprolol succinate and hydrochlorothiazide	Concordia Pharmaceuticals Inc.	NDA	Current
59212-087	Dutoprol	metoprolol succinate and hydrochlorothiazide	Concordia Pharmaceuticals Inc.	NDA	Current
59212-087	Dutoprol	metoprolol succinate and hydrochlorothiazide	Concordia Pharmaceuticals Inc.	NDA	Current
59212-095	Dutoprol	metoprolol succinate and hydrochlorothiazide	Concordia Pharmaceuticals Inc.	NDA	Current
59212-095	Dutoprol	metoprolol succinate and hydrochlorothiazide	Concordia Pharmaceuticals Inc.	NDA	Current
59212-095	Dutoprol	metoprolol succinate and hydrochlorothiazide	Concordia Pharmaceuticals Inc.	NDA	Current
59212-095	Dutoprol	metoprolol succinate and hydrochlorothiazide	Concordia Pharmaceuticals Inc.	NDA	Current
59212-095	Dutoprol	metoprolol succinate and hydrochlorothiazide	Concordia Pharmaceuticals Inc.	NDA	Current
59212-095	Dutoprol	metoprolol succinate and hydrochlorothiazide	Concordia Pharmaceuticals Inc.	NDA	Current
59212-095	Dutoprol	metoprolol succinate and hydrochlorothiazide	Concordia Pharmaceuticals Inc.	NDA	Current
59212-097	Dutoprol	metoprolol succinate and hydrochlorothiazide	Concordia Pharmaceuticals Inc.	NDA	Current
59212-097	Dutoprol	metoprolol succinate and hydrochlorothiazide	Concordia Pharmaceuticals Inc.	NDA	Current
59212-097	Dutoprol	metoprolol succinate and hydrochlorothiazide	Concordia Pharmaceuticals Inc.	NDA	Current
59212-097	Dutoprol	metoprolol succinate and hydrochlorothiazide	Concordia Pharmaceuticals Inc.	NDA	Current
59212-097	Dutoprol	metoprolol succinate and hydrochlorothiazide	Concordia Pharmaceuticals Inc.	NDA	Current
59212-097	Dutoprol	metoprolol succinate and hydrochlorothiazide	Concordia Pharmaceuticals Inc.	NDA	Current
59212-097	Dutoprol	metoprolol succinate and hydrochlorothiazide	Concordia Pharmaceuticals Inc.	NDA	Current
69499-321	metoprolol succinate and hydrochlorothiazide	metoprolol succinate and hydrochlorothiazide	Solubiomix	NDA	Current
69499-321	metoprolol succinate and hydrochlorothiazide	metoprolol succinate and hydrochlorothiazide	Solubiomix	NDA	Current
69499-323	metoprolol succinate and hydrochlorothiazide	metoprolol succinate and hydrochlorothiazide	Solubiomix	NDA	Current
69499-323	metoprolol succinate and hydrochlorothiazide	metoprolol succinate and hydrochlorothiazide	Solubiomix	NDA	Current
69499-324	metoprolol succinate and hydrochlorothiazide	metoprolol succinate and hydrochlorothiazide	Solubiomix	NDA	Current
69499-324	metoprolol succinate and hydrochlorothiazide	metoprolol succinate and hydrochlorothiazide	Solubiomix	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69922	SUPPL	2022-01-19
69896	SUPPL	2022-01-18
64428	SUPPL	2020-08-27
64358	SUPPL	2020-08-21
49491	SUPPL	2017-08-21
49439	SUPPL	2017-08-17
6539	SUPPL	2014-10-22
37947	SUPPL	2014-10-21
6538	SUPPL	2011-12-22
37946	SUPPL	2011-12-19
37945	SUPPL	2011-03-07
28913	SUPPL	2011-03-07
16636	SUPPL	2011-03-07
6537	SUPPL	2011-03-07
21884	ORIG	2008-05-07
6536	ORIG	2006-09-18
37944	ORIG	2006-08-29