Application 206367

Type: ANDA
Sponsor: INVAGEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	TABLET;ORAL	EQ 2.5MG BASE	No	No
002	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	TABLET;ORAL	EQ 5MG BASE	No	No
003	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	TABLET;ORAL	EQ 10MG BASE	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	TE codes	Approval date
A206367-001	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2015-12-10
A206367-002	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2015-12-10
A206367-003	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2015-12-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A206367-001	AB
A206367-002	AB
A206367-003	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 4 · 129 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	A206367-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2015-12-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206367-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2015-12-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206367-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2015-12-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206367-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2015-12-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206367-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2015-12-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206367-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2015-12-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206367-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2015-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206367-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2015-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206367-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2015-12-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206367-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2015-12-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206367-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2015-12-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206367-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2015-12-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206367-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2015-12-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206367-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2015-12-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206367-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2015-12-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206367-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2015-12-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206367-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2015-12-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206367-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2015-12-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206367-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2015-12-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206367-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2015-12-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206367-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2015-12-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206367-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2015-12-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206367-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2015-12-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206367-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2015-12-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206367-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2015-12-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206367-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2015-12-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206367-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2015-12-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206367-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2015-12-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206367-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2015-12-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206367-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2015-12-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206367-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2015-12-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206367-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2015-12-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206367-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2015-12-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206367-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2015-12-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206367-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2015-12-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206367-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2015-12-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206367-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2015-12-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206367-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2015-12-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206367-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2015-12-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206367-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2015-12-10	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A206367-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206367-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206367-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206367-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206367-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206367-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206367-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206367-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206367-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206367-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206367-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206367-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206367-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206367-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206367-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206367-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206367-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206367-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206367-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206367-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206367-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206367-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206367-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206367-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206367-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206367-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206367-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206367-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206367-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206367-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206367-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206367-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206367-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206367-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206367-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206367-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206367-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206367-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206367-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206367-001	AB	1	`301d65b070ca…`

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
Amlodipine besylate	AMLODIPINE BESYLATE	Exelan Pharmaceuticals, Inc.	1a24433f-4464-4c6d-9456-ed1ce38e8ec4	2022-03-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206367 application number: ANDA206367 ndc (product): 76282-508 ndc (product): 76282-509 ndc (product): 76282-507

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
76282-507	Amlodipine besylate	Amlodipine besylate	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-508	Amlodipine besylate	Amlodipine besylate	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-509	Amlodipine besylate	Amlodipine besylate	Exelan Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
32802	ORIG	2015-12-16