Application 077169

Type: ANDA
Sponsor: ELITE LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ISRADIPINE	ISRADIPINE	CAPSULE;ORAL	2.5MG	No	No
002	ISRADIPINE	ISRADIPINE	CAPSULE;ORAL	5MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077169-001	ISRADIPINE	ISRADIPINE	2.5MG	CAPSULE / ORAL	AB		2006-04-24
A077169-002	ISRADIPINE	ISRADIPINE	5MG	CAPSULE / ORAL	AB		2006-04-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A077169-001	AB
A077169-002	AB

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 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077169-001	ISRADIPINE	2.5MG	CAPSULE / ORAL	AB	2006-04-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077169-002	ISRADIPINE	5MG	CAPSULE / ORAL	AB	2006-04-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077169-001	ISRADIPINE	2.5MG	CAPSULE / ORAL	AB	2006-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077169-002	ISRADIPINE	5MG	CAPSULE / ORAL	AB	2006-04-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077169-001	ISRADIPINE	2.5MG	CAPSULE / ORAL	AB	2006-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077169-002	ISRADIPINE	5MG	CAPSULE / ORAL	AB	2006-04-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077169-001	ISRADIPINE	2.5MG	CAPSULE / ORAL	AB	2006-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077169-002	ISRADIPINE	5MG	CAPSULE / ORAL	AB	2006-04-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077169-001	ISRADIPINE	2.5MG	CAPSULE / ORAL	AB	2006-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077169-002	ISRADIPINE	5MG	CAPSULE / ORAL	AB	2006-04-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077169-001	ISRADIPINE	2.5MG	CAPSULE / ORAL	AB	2006-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077169-002	ISRADIPINE	5MG	CAPSULE / ORAL	AB	2006-04-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077169-001	ISRADIPINE	2.5MG	CAPSULE / ORAL	AB	2006-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077169-002	ISRADIPINE	5MG	CAPSULE / ORAL	AB	2006-04-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077169-001	ISRADIPINE	2.5MG	CAPSULE / ORAL	AB	2006-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077169-002	ISRADIPINE	5MG	CAPSULE / ORAL	AB	2006-04-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077169-001	ISRADIPINE	2.5MG	CAPSULE / ORAL	AB	2006-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077169-002	ISRADIPINE	5MG	CAPSULE / ORAL	AB	2006-04-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077169-001	ISRADIPINE	2.5MG	CAPSULE / ORAL	AB	2006-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077169-002	ISRADIPINE	5MG	CAPSULE / ORAL	AB	2006-04-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077169-001	ISRADIPINE	2.5MG	CAPSULE / ORAL	AB	2006-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077169-002	ISRADIPINE	5MG	CAPSULE / ORAL	AB	2006-04-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077169-001	ISRADIPINE	2.5MG	CAPSULE / ORAL	AB	2006-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077169-002	ISRADIPINE	5MG	CAPSULE / ORAL	AB	2006-04-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077169-001	ISRADIPINE	2.5MG	CAPSULE / ORAL	AB	2006-04-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077169-002	ISRADIPINE	5MG	CAPSULE / ORAL	AB	2006-04-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077169-001	ISRADIPINE	2.5MG	CAPSULE / ORAL	AB	2006-04-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077169-002	ISRADIPINE	5MG	CAPSULE / ORAL	AB	2006-04-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077169-001	ISRADIPINE	2.5MG	CAPSULE / ORAL	AB	2006-04-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077169-002	ISRADIPINE	5MG	CAPSULE / ORAL	AB	2006-04-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077169-001	ISRADIPINE	2.5MG	CAPSULE / ORAL	AB	2006-04-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077169-002	ISRADIPINE	5MG	CAPSULE / ORAL	AB	2006-04-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077169-001	ISRADIPINE	2.5MG	CAPSULE / ORAL	AB	2006-04-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077169-002	ISRADIPINE	5MG	CAPSULE / ORAL	AB	2006-04-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077169-001	ISRADIPINE	2.5MG	CAPSULE / ORAL	AB	2006-04-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077169-002	ISRADIPINE	5MG	CAPSULE / ORAL	AB	2006-04-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077169-001	ISRADIPINE	2.5MG	CAPSULE / ORAL	AB	2006-04-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077169-002	ISRADIPINE	5MG	CAPSULE / ORAL	AB	2006-04-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077169-001	ISRADIPINE	2.5MG	CAPSULE / ORAL	AB	2006-04-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077169-002	ISRADIPINE	5MG	CAPSULE / ORAL	AB	2006-04-24	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077169-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077169-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077169-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077169-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077169-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077169-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077169-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077169-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077169-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077169-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077169-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077169-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077169-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077169-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077169-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077169-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077169-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077169-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077169-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077169-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077169-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077169-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077169-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077169-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077169-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077169-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077169-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077169-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077169-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077169-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077169-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077169-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077169-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077169-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077169-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077169-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077169-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077169-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077169-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077169-002	AB	1	`74a2ff9319b5…`

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
Isradipine	ISRADIPINE	Elite Laboratories, Inc.	acf7c376-6cb6-4857-b455-0bf5da29346c	2019-12-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077169 application number: ANDA077169 ndc (product): 64850-911 ndc (product): 64850-910

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 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42806-263	Isradipine	Isradipine	Epic Pharma, LLC	ANDA	Current
42806-263	Isradipine	Isradipine	Epic Pharma, LLC	ANDA	Current
42806-264	Isradipine	Isradipine	Epic Pharma, LLC	ANDA	Current
42806-264	Isradipine	Isradipine	Epic Pharma, LLC	ANDA	Current
60429-385	Isradipine	Isradipine	Golden State Medical Supply, Inc.	ANDA	Current
60429-385	Isradipine	Isradipine	Golden State Medical Supply, Inc.	ANDA	Current
60429-386	Isradipine	Isradipine	Golden State Medical Supply, Inc.	ANDA	Current
60429-386	Isradipine	Isradipine	Golden State Medical Supply, Inc.	ANDA	Current
64850-910	Isradipine	Isradipine	Elite Laboratories, Inc.	ANDA	Current
64850-911	Isradipine	Isradipine	Elite Laboratories, Inc.	ANDA	Current
68462-807	Isradipine	Isradipine	Glenmark Pharmaceuticals Inc.,USA	ANDA	Current
68462-807	Isradipine	Isradipine	Glenmark Pharmaceuticals Inc.,USA	ANDA	Current
68462-808	Isradipine	Isradipine	Glenmark Pharmaceuticals Inc.,USA	ANDA	Current
68462-808	Isradipine	Isradipine	Glenmark Pharmaceuticals Inc.,USA	ANDA	Current