Application 020591

Type: NDA
Sponsor: ABBVIE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TARKA	TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	2MG;180MG	Yes	No
002	TARKA	TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	4MG;240MG	Yes	Yes
003	TARKA	TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1MG;240MG	Yes	No
004	TARKA	TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	2MG;240MG	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N020591-001	TARKA	TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE	2MG;180MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22
N020591-002	TARKA	TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE	4MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22
N020591-003	TARKA	TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE	1MG;240MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22
N020591-004	TARKA	TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE	2MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22

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 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020591-001	TARKA	2MG;180MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020591-002	TARKA	4MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020591-003	TARKA	1MG;240MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020591-004	TARKA	2MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020591-001	TARKA	2MG;180MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020591-002	TARKA	4MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020591-003	TARKA	1MG;240MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020591-004	TARKA	2MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020591-001	TARKA	2MG;180MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020591-002	TARKA	4MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020591-003	TARKA	1MG;240MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020591-004	TARKA	2MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020591-001	TARKA	2MG;180MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020591-002	TARKA	4MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020591-003	TARKA	1MG;240MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020591-004	TARKA	2MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020591-001	TARKA	2MG;180MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020591-002	TARKA	4MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020591-003	TARKA	1MG;240MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020591-004	TARKA	2MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020591-001	TARKA	2MG;180MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020591-002	TARKA	4MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020591-003	TARKA	1MG;240MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020591-004	TARKA	2MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020591-001	TARKA	2MG;180MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020591-002	TARKA	4MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020591-003	TARKA	1MG;240MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020591-004	TARKA	2MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020591-001	TARKA	2MG;180MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020591-002	TARKA	4MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020591-003	TARKA	1MG;240MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020591-004	TARKA	2MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020591-001	TARKA	2MG;180MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020591-002	TARKA	4MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020591-003	TARKA	1MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020591-004	TARKA	2MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020591-001	TARKA	2MG;180MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020591-002	TARKA	4MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020591-003	TARKA	1MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020591-004	TARKA	2MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-10-22	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020591-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020591-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020591-004	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020591-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020591-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020591-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020591-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020591-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020591-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020591-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020591-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020591-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020591-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020591-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020591-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020591-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020591-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020591-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020591-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020591-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020591-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020591-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020591-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020591-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020591-004	AB	1	`ea99ee380514…`

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 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0074-3287	Tarka	Trandolapril and Verapamil Hydrochloride	AbbVie Inc.	NDA	Current
0074-3287	Tarka	Trandolapril and Verapamil Hydrochloride	AbbVie Inc.	NDA	Current
0074-3287	Tarka	Trandolapril and Verapamil Hydrochloride	AbbVie Inc.	NDA	Current
0074-3289	Tarka	Trandolapril and Verapamil Hydrochloride	AbbVie Inc.	NDA	Current
0074-3289	Tarka	Trandolapril and Verapamil Hydrochloride	AbbVie Inc.	NDA	Current
0074-3289	Tarka	Trandolapril and Verapamil Hydrochloride	AbbVie Inc.	NDA	Current
0074-3290	Tarka	Trandolapril and Verapamil Hydrochloride	AbbVie Inc.	NDA	Current
0074-3290	Tarka	Trandolapril and Verapamil Hydrochloride	AbbVie Inc.	NDA	Current
0074-3290	Tarka	Trandolapril and Verapamil Hydrochloride	AbbVie Inc.	NDA	Current
59762-0122	Trandolapril and Verapamil Hydrochloride	Trandolapril and Verapamil Hydrochloride	Greenstone LLC	NDA	Current
59762-0122	Trandolapril and Verapamil Hydrochloride	Trandolapril and Verapamil Hydrochloride	Greenstone LLC	NDA	Current
59762-0122	Trandolapril and Verapamil Hydrochloride	Trandolapril and Verapamil Hydrochloride	Greenstone LLC	NDA	Current
59762-0122	Trandolapril and Verapamil Hydrochloride	Trandolapril and Verapamil Hydrochloride	Greenstone LLC	NDA	Current
59762-0132	Trandolapril and Verapamil Hydrochloride	Trandolapril and Verapamil Hydrochloride	Greenstone LLC	NDA	Current
59762-0132	Trandolapril and Verapamil Hydrochloride	Trandolapril and Verapamil Hydrochloride	Greenstone LLC	NDA	Current
59762-0132	Trandolapril and Verapamil Hydrochloride	Trandolapril and Verapamil Hydrochloride	Greenstone LLC	NDA	Current
59762-0132	Trandolapril and Verapamil Hydrochloride	Trandolapril and Verapamil Hydrochloride	Greenstone LLC	NDA	Current
59762-0142	Trandolapril and Verapamil Hydrochloride	Trandolapril and Verapamil Hydrochloride	Greenstone LLC	NDA	Current
59762-0142	Trandolapril and Verapamil Hydrochloride	Trandolapril and Verapamil Hydrochloride	Greenstone LLC	NDA	Current
59762-0142	Trandolapril and Verapamil Hydrochloride	Trandolapril and Verapamil Hydrochloride	Greenstone LLC	NDA	Current
59762-0142	Trandolapril and Verapamil Hydrochloride	Trandolapril and Verapamil Hydrochloride	Greenstone LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
59821	SUPPL	2019-08-22
59785	SUPPL	2019-08-21
49246	SUPPL	2017-08-04
49238	SUPPL	2017-08-04
25255	SUPPL	2016-07-13
12789	SUPPL	2016-07-13
34903	SUPPL	2016-02-02
2806	SUPPL	2016-02-01
12788	SUPPL	2015-01-08
2805	SUPPL	2014-12-30
34902	SUPPL	2012-09-14
25254	SUPPL	2012-09-14
25253	SUPPL	2012-01-30
12787	SUPPL	2012-01-23
2804	SUPPL	2011-11-16
34901	SUPPL	2011-11-14
34900	SUPPL	2011-09-16
25252	SUPPL	2011-09-16
2803	SUPPL	2011-08-31
12786	SUPPL	2011-08-29
25251	SUPPL	2009-03-06
2802	SUPPL	2008-03-04