Application 214089

Type: ANDA
Sponsor: HAVIX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	CAPSULE;ORAL	150MG	No	No
002	MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	CAPSULE;ORAL	200MG	No	No
003	MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	CAPSULE;ORAL	250MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A214089-001	MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2021-10-01
A214089-002	MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2021-10-01
A214089-003	MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-10-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214089-001	AB
A214089-002	AB
A214089-003	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 3 · 99 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
2026-02-19 14:30 UTC	2026-02	A214089-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2021-10-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214089-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2021-10-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214089-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-10-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214089-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2021-10-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214089-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2021-10-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214089-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-10-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214089-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2021-10-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214089-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2021-10-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214089-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-10-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214089-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2021-10-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214089-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2021-10-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214089-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-10-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214089-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2021-10-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214089-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2021-10-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214089-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-10-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214089-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2021-10-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214089-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2021-10-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214089-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-10-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214089-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2021-10-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214089-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2021-10-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214089-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-10-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214089-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2021-10-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214089-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2021-10-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214089-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-10-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214089-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2021-10-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214089-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2021-10-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214089-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-10-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214089-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2021-10-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214089-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2021-10-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214089-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-10-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214089-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2021-10-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214089-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2021-10-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214089-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-10-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214089-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2021-10-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214089-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2021-10-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214089-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-10-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214089-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2021-10-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214089-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2021-10-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214089-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-10-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214089-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2021-10-01	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A214089-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214089-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214089-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214089-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214089-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214089-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214089-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214089-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214089-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214089-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214089-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214089-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214089-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214089-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214089-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214089-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214089-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214089-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214089-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214089-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214089-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214089-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214089-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214089-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214089-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214089-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214089-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214089-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214089-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214089-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214089-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214089-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214089-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214089-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214089-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214089-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214089-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214089-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214089-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214089-001	AB	1	`8072bd15b7f6…`

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Bryant Ranch Prepack	3aec79aa-9dfb-495f-9280-2b830dc7eae9	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214089 application number: ANDA214089
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Bryant Ranch Prepack	68987377-c7c2-493b-be42-30379ec432bc	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214089 application number: ANDA214089
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Bryant Ranch Prepack	0ff45dbf-b555-4f55-a286-98bfaea9ea29	2024-10-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214089 application number: ANDA214089
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Bryant Ranch Prepack	6cd564bd-24e3-481b-b998-f69f65d67fbe	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214089 application number: ANDA214089
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Bryant Ranch Prepack	2f4239ef-a28a-40d3-9617-2029d492829d	2024-05-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214089 application number: ANDA214089
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Bryant Ranch Prepack	9099b620-eae9-48f9-9d5f-8fd22c32b2b0	2024-04-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214089 application number: ANDA214089 ndc (product): 63629-9179
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Bryant Ranch Prepack	41930321-15e3-4ddf-ba5d-3655ce5f2923	2023-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214089 application number: ANDA214089 ndc (product): 63629-9180
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Bryant Ranch Prepack	217fbd7a-1052-42e4-9e84-70519b7b0b7a	2023-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214089 application number: ANDA214089 ndc (product): 63629-9181
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Senores Pharmaceuticals, Inc.	c4a60f9e-fed1-4172-adc4-0be84ac65db9	2023-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214089 application number: ANDA214089 ndc (product): 82012-029 ndc (product): 82012-028
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	2d0c61ca-4c99-42f9-8f00-e0e9d2672a39	2023-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214089 application number: ANDA214089 ndc (product): 62756-956 ndc (product): 62756-957 ndc (product): 62756-955

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62756-955	MEXILETINE HYDROCHLORIDE	mexiletine hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-956	MEXILETINE HYDROCHLORIDE	mexiletine hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-957	MEXILETINE HYDROCHLORIDE	mexiletine hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63629-9179	MEXILETINE HYDROCHLORIDE	mexiletine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-9179	MEXILETINE HYDROCHLORIDE	mexiletine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-9180	MEXILETINE HYDROCHLORIDE	mexiletine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-9180	MEXILETINE HYDROCHLORIDE	mexiletine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-9181	MEXILETINE HYDROCHLORIDE	mexiletine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-9181	MEXILETINE HYDROCHLORIDE	mexiletine hydrochloride	Bryant Ranch Prepack	ANDA	Current
82012-028	MEXILETINE HYDROCHLORIDE	mexiletine hydrochloride	Senores Pharmaceuticals, Inc.	ANDA	Current
82012-029	MEXILETINE HYDROCHLORIDE	mexiletine hydrochloride	Senores Pharmaceuticals, Inc.	ANDA	Current