Application 078263

Type: ANDA
Sponsor: LUPIN LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PERINDOPRIL ERBUMINE	PERINDOPRIL ERBUMINE	TABLET;ORAL	2MG	No	No
002	PERINDOPRIL ERBUMINE	PERINDOPRIL ERBUMINE	TABLET;ORAL	4MG	No	No
003	PERINDOPRIL ERBUMINE	PERINDOPRIL ERBUMINE	TABLET;ORAL	8MG	No	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	Approval date
A078263-001	PERINDOPRIL ERBUMINE	PERINDOPRIL ERBUMINE	2MG	TABLET / ORAL	2010-01-27
A078263-002	PERINDOPRIL ERBUMINE	PERINDOPRIL ERBUMINE	4MG	TABLET / ORAL	2010-01-27
A078263-003	PERINDOPRIL ERBUMINE	PERINDOPRIL ERBUMINE	8MG	TABLET / ORAL	2010-01-27

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	Approval date	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078263-002	PERINDOPRIL ERBUMINE	4MG	TABLET / ORAL	2010-01-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078263-003	PERINDOPRIL ERBUMINE	8MG	TABLET / ORAL	2010-01-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078263-001	PERINDOPRIL ERBUMINE	2MG	TABLET / ORAL	2010-01-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078263-002	PERINDOPRIL ERBUMINE	4MG	TABLET / ORAL	2010-01-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078263-003	PERINDOPRIL ERBUMINE	8MG	TABLET / ORAL	2010-01-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078263-001	PERINDOPRIL ERBUMINE	2MG	TABLET / ORAL	2010-01-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078263-002	PERINDOPRIL ERBUMINE	4MG	TABLET / ORAL	2010-01-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078263-003	PERINDOPRIL ERBUMINE	8MG	TABLET / ORAL	2010-01-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078263-001	PERINDOPRIL ERBUMINE	2MG	TABLET / ORAL	2010-01-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078263-002	PERINDOPRIL ERBUMINE	4MG	TABLET / ORAL	2010-01-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078263-003	PERINDOPRIL ERBUMINE	8MG	TABLET / ORAL	2010-01-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078263-001	PERINDOPRIL ERBUMINE	2MG	TABLET / ORAL	2010-01-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078263-002	PERINDOPRIL ERBUMINE	4MG	TABLET / ORAL	2010-01-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078263-003	PERINDOPRIL ERBUMINE	8MG	TABLET / ORAL	2010-01-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078263-001	PERINDOPRIL ERBUMINE	2MG	TABLET / ORAL	2010-01-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078263-002	PERINDOPRIL ERBUMINE	4MG	TABLET / ORAL	2010-01-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078263-003	PERINDOPRIL ERBUMINE	8MG	TABLET / ORAL	2010-01-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078263-001	PERINDOPRIL ERBUMINE	2MG	TABLET / ORAL	2010-01-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078263-002	PERINDOPRIL ERBUMINE	4MG	TABLET / ORAL	2010-01-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078263-003	PERINDOPRIL ERBUMINE	8MG	TABLET / ORAL	2010-01-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078263-001	PERINDOPRIL ERBUMINE	2MG	TABLET / ORAL	2010-01-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078263-002	PERINDOPRIL ERBUMINE	4MG	TABLET / ORAL	2010-01-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078263-003	PERINDOPRIL ERBUMINE	8MG	TABLET / ORAL	2010-01-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078263-001	PERINDOPRIL ERBUMINE	2MG	TABLET / ORAL	2010-01-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078263-002	PERINDOPRIL ERBUMINE	4MG	TABLET / ORAL	2010-01-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078263-003	PERINDOPRIL ERBUMINE	8MG	TABLET / ORAL	2010-01-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078263-001	PERINDOPRIL ERBUMINE	2MG	TABLET / ORAL	2010-01-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078263-002	PERINDOPRIL ERBUMINE	4MG	TABLET / ORAL	2010-01-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078263-003	PERINDOPRIL ERBUMINE	8MG	TABLET / ORAL	2010-01-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078263-001	PERINDOPRIL ERBUMINE	2MG	TABLET / ORAL	2010-01-27	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078263-002	PERINDOPRIL ERBUMINE	4MG	TABLET / ORAL	2010-01-27	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078263-003	PERINDOPRIL ERBUMINE	8MG	TABLET / ORAL	2010-01-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078263-001	PERINDOPRIL ERBUMINE	2MG	TABLET / ORAL	2010-01-27	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078263-002	PERINDOPRIL ERBUMINE	4MG	TABLET / ORAL	2010-01-27	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078263-003	PERINDOPRIL ERBUMINE	8MG	TABLET / ORAL	2010-01-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078263-001	PERINDOPRIL ERBUMINE	2MG	TABLET / ORAL	2010-01-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078263-002	PERINDOPRIL ERBUMINE	4MG	TABLET / ORAL	2010-01-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078263-003	PERINDOPRIL ERBUMINE	8MG	TABLET / ORAL	2010-01-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078263-001	PERINDOPRIL ERBUMINE	2MG	TABLET / ORAL	2010-01-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078263-002	PERINDOPRIL ERBUMINE	4MG	TABLET / ORAL	2010-01-27	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Perindopril Erbumine	PERINDOPRIL ERBUMINE	Aurobindo Pharma Limited	87768fbf-7c63-47da-8925-0316f343d6ef	2024-03-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Perindopril Erbumine generic name: PERINDOPRIL ERBUMINE

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68180-235	Perindopril Erbumine	Perindopril Erbumine	Lupin Pharmaceuticals, Inc	ANDA	Current
68180-236	Perindopril Erbumine	Perindopril Erbumine	Lupin Pharmaceuticals, Inc	ANDA	Current
68180-237	Perindopril Erbumine	Perindopril Erbumine	Lupin Pharmaceuticals, Inc	ANDA	Current