Application 020528

Type: NDA
Sponsor: ABBVIE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MAVIK	TRANDOLAPRIL	TABLET;ORAL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	MAVIK	TRANDOLAPRIL	TABLET;ORAL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	MAVIK	TRANDOLAPRIL	TABLET;ORAL	4MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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
N020528-001	MAVIK	TRANDOLAPRIL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-04-26
N020528-002	MAVIK	TRANDOLAPRIL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-04-26
N020528-003	MAVIK	TRANDOLAPRIL	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-04-26

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captures of this ZIP	2024-08	N020528-002	MAVIK	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-04-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020528-003	MAVIK	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-04-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020528-001	MAVIK	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-04-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020528-002	MAVIK	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-04-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020528-003	MAVIK	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-04-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020528-001	MAVIK	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-04-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020528-002	MAVIK	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-04-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020528-003	MAVIK	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-04-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020528-001	MAVIK	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-04-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020528-002	MAVIK	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-04-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020528-003	MAVIK	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-04-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020528-001	MAVIK	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-04-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020528-002	MAVIK	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-04-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020528-003	MAVIK	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-04-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020528-001	MAVIK	1MG	TABLET / ORAL	RLD	1996-04-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020528-002	MAVIK	2MG	TABLET / ORAL	RLD	1996-04-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020528-003	MAVIK	4MG	TABLET / ORAL	RLD	1996-04-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020528-001	MAVIK	1MG	TABLET / ORAL	RLD	1996-04-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020528-002	MAVIK	2MG	TABLET / ORAL	RLD	1996-04-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020528-003	MAVIK	4MG	TABLET / ORAL	RLD	1996-04-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020528-001	MAVIK	1MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1996-04-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020528-002	MAVIK	2MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1996-04-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020528-003	MAVIK	4MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1996-04-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020528-001	MAVIK	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-04-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020528-002	MAVIK	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-04-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020528-003	MAVIK	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-04-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020528-001	MAVIK	1MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1996-04-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020528-002	MAVIK	2MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1996-04-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020528-003	MAVIK	4MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1996-04-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020528-001	MAVIK	1MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1996-04-26	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020528-002	MAVIK	2MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1996-04-26	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020528-003	MAVIK	4MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1996-04-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020528-001	MAVIK	1MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1996-04-26	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020528-002	MAVIK	2MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1996-04-26	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020528-003	MAVIK	4MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1996-04-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020528-001	MAVIK	1MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1996-04-26	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020528-002	MAVIK	2MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1996-04-26	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020528-003	MAVIK	4MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1996-04-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020528-001	MAVIK	1MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1996-04-26	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020528-002	MAVIK	2MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1996-04-26	`c0c555d07b60…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trandolapril	TRANDOLAPRIL	Lupin Pharmaceuticals, Inc.	8143a6cf-dadc-4ef7-a8db-d16d7150ad34	2025-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRANDOLAPRIL
Trandolapril	TRANDOLAPRIL	Bryant Ranch Prepack	514f53e6-ff6b-4d02-9db9-2575b15aa5f0	2025-09-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRANDOLAPRIL
Trandolapril	TRANDOLAPRIL	Bryant Ranch Prepack	57f8aac6-3bd3-4ae1-aab2-759c8bc23292	2024-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRANDOLAPRIL
Trandolapril	TRANDOLAPRIL	Aurobindo Pharma Limited	6f25ed16-e5e9-4170-b4b4-3b460887779e	2024-04-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRANDOLAPRIL
Trandolapril	TRANDOLAPRIL	Rising Pharma Holdings, Inc.	0107d19a-b43a-4a36-8b8c-4dfc247630e9	2024-04-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRANDOLAPRIL

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
49247	SUPPL	2017-08-04
49237	SUPPL	2017-08-04
12689	SUPPL	2016-02-02
25127	SUPPL	2016-02-01
34786	SUPPL	2015-01-09
25126	SUPPL	2014-12-30
34785	SUPPL	2012-09-14
25125	SUPPL	2012-09-14
12688	SUPPL	2012-03-06
25124	SUPPL	2012-01-30
2678	SUPPL	2012-01-30
12687	SUPPL	2012-01-23
2677	SUPPL	2011-11-14
34784	SUPPL	2011-09-16
25123	SUPPL	2011-09-16
34782	SUPPL	2010-05-03
2676	SUPPL	2010-04-23
34783	SUPPL	2009-04-16
25122	SUPPL	2009-04-16
23583	ORIG	2006-06-09
2675	SUPPL	2004-03-03
41416	SUPPL	1997-07-02
57459	ORIG	1996-04-26