Application 077307

Type: ANDA
Sponsor: CIPLA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRANDOLAPRIL	TRANDOLAPRIL	TABLET;ORAL	2MG	No	No
002	TRANDOLAPRIL	TRANDOLAPRIL	TABLET;ORAL	1MG	No	No
003	TRANDOLAPRIL	TRANDOLAPRIL	TABLET;ORAL	4MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A077307-001	TRANDOLAPRIL	TRANDOLAPRIL	2MG	TABLET / ORAL	2007-06-12
A077307-002	TRANDOLAPRIL	TRANDOLAPRIL	1MG	TABLET / ORAL	2007-06-12
A077307-003	TRANDOLAPRIL	TRANDOLAPRIL	4MG	TABLET / ORAL	2007-06-12

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077307-002	TRANDOLAPRIL	1MG	TABLET / ORAL	2007-06-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077307-003	TRANDOLAPRIL	4MG	TABLET / ORAL	2007-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077307-001	TRANDOLAPRIL	2MG	TABLET / ORAL	2007-06-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077307-002	TRANDOLAPRIL	1MG	TABLET / ORAL	2007-06-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077307-003	TRANDOLAPRIL	4MG	TABLET / ORAL	2007-06-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077307-001	TRANDOLAPRIL	2MG	TABLET / ORAL	2007-06-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077307-002	TRANDOLAPRIL	1MG	TABLET / ORAL	2007-06-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077307-003	TRANDOLAPRIL	4MG	TABLET / ORAL	2007-06-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077307-001	TRANDOLAPRIL	2MG	TABLET / ORAL	2007-06-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077307-002	TRANDOLAPRIL	1MG	TABLET / ORAL	2007-06-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077307-003	TRANDOLAPRIL	4MG	TABLET / ORAL	2007-06-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077307-001	TRANDOLAPRIL	2MG	TABLET / ORAL	2007-06-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077307-002	TRANDOLAPRIL	1MG	TABLET / ORAL	2007-06-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077307-003	TRANDOLAPRIL	4MG	TABLET / ORAL	2007-06-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077307-001	TRANDOLAPRIL	2MG	TABLET / ORAL	2007-06-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077307-002	TRANDOLAPRIL	1MG	TABLET / ORAL	2007-06-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077307-003	TRANDOLAPRIL	4MG	TABLET / ORAL	2007-06-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077307-001	TRANDOLAPRIL	2MG	TABLET / ORAL	2007-06-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077307-002	TRANDOLAPRIL	1MG	TABLET / ORAL	2007-06-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077307-003	TRANDOLAPRIL	4MG	TABLET / ORAL	2007-06-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077307-001	TRANDOLAPRIL	2MG	TABLET / ORAL	2007-06-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077307-002	TRANDOLAPRIL	1MG	TABLET / ORAL	2007-06-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077307-003	TRANDOLAPRIL	4MG	TABLET / ORAL	2007-06-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077307-001	TRANDOLAPRIL	2MG	TABLET / ORAL	2007-06-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077307-002	TRANDOLAPRIL	1MG	TABLET / ORAL	2007-06-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077307-003	TRANDOLAPRIL	4MG	TABLET / ORAL	2007-06-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077307-001	TRANDOLAPRIL	2MG	TABLET / ORAL	2007-06-12	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077307-002	TRANDOLAPRIL	1MG	TABLET / ORAL	2007-06-12	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077307-003	TRANDOLAPRIL	4MG	TABLET / ORAL	2007-06-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077307-001	TRANDOLAPRIL	2MG	TABLET / ORAL	2007-06-12	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077307-002	TRANDOLAPRIL	1MG	TABLET / ORAL	2007-06-12	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077307-003	TRANDOLAPRIL	4MG	TABLET / ORAL	2007-06-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077307-001	TRANDOLAPRIL	2MG	TABLET / ORAL	2007-06-12	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077307-002	TRANDOLAPRIL	1MG	TABLET / ORAL	2007-06-12	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077307-003	TRANDOLAPRIL	4MG	TABLET / ORAL	2007-06-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077307-001	TRANDOLAPRIL	2MG	TABLET / ORAL	2007-06-12	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077307-002	TRANDOLAPRIL	1MG	TABLET / ORAL	2007-06-12	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077307-003	TRANDOLAPRIL	4MG	TABLET / ORAL	2007-06-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077307-001	TRANDOLAPRIL	2MG	TABLET / ORAL	2007-06-12	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077307-002	TRANDOLAPRIL	1MG	TABLET / ORAL	2007-06-12	`3f01610625f2…`

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 · 6 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 brand name: Trandolapril generic name: TRANDOLAPRIL
Trandolapril	TRANDOLAPRIL	Bryant Ranch Prepack	514f53e6-ff6b-4d02-9db9-2575b15aa5f0	2025-09-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trandolapril generic name: TRANDOLAPRIL
Trandolapril	TRANDOLAPRIL	Bryant Ranch Prepack	57f8aac6-3bd3-4ae1-aab2-759c8bc23292	2024-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trandolapril generic name: TRANDOLAPRIL
Trandolapril	TRANDOLAPRIL	Aurobindo Pharma Limited	6f25ed16-e5e9-4170-b4b4-3b460887779e	2024-04-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trandolapril generic name: TRANDOLAPRIL
Trandolapril	TRANDOLAPRIL	Rising Pharma Holdings, Inc.	0107d19a-b43a-4a36-8b8c-4dfc247630e9	2024-04-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trandolapril generic name: TRANDOLAPRIL
Trandolapril	TRANDOLAPRIL TABLETS	Epic Pharma, LLC	10f25119-9970-46fe-bf36-6fec6064895b	2018-07-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand 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
44349	ORIG	2007-06-18