Application 076856

Type: ANDA
Sponsor: IMPAX LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DANTROLENE SODIUM	DANTROLENE SODIUM	CAPSULE;ORAL	25MG	No	No
002	DANTROLENE SODIUM	DANTROLENE SODIUM	CAPSULE;ORAL	50MG	No	No
003	DANTROLENE SODIUM	DANTROLENE SODIUM	CAPSULE;ORAL	100MG	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
A076856-001	DANTROLENE SODIUM	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01
A076856-002	DANTROLENE SODIUM	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01
A076856-003	DANTROLENE SODIUM	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076856-001	AB
A076856-002	AB
A076856-003	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 · 123 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	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076856-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076856-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076856-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076856-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076856-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076856-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076856-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076856-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076856-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076856-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076856-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076856-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076856-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076856-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076856-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076856-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076856-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076856-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076856-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076856-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076856-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076856-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076856-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076856-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076856-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076856-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A076856-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076856-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076856-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076856-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076856-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076856-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076856-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076856-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076856-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076856-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076856-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076856-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076856-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076856-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076856-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076856-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076856-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076856-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076856-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076856-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076856-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076856-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076856-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076856-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076856-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076856-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076856-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076856-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076856-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076856-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076856-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076856-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076856-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076856-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076856-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076856-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076856-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076856-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076856-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076856-001	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dantrolene Sodium	DANTROLENE SODIUM	Major Pharmaceuticals	90414d2f-7b2c-47f9-a096-2e7b7dd052de	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076856 application number: ANDA076856 ndc (product): 0904-7211
Dantrolene Sodium	DANTROLENE SODIUM	Amneal Pharmaceuticals of New York LLC	c3c45b27-f786-456e-95d6-2e38ef36190a	2026-05-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076856 application number: ANDA076856 ndc (product): 0115-4433 ndc (product): 0115-4411 ndc (product): 0115-4422
Dantrolene Sodium	DANTROLENE SODIUM	Cardinal Health 107, LLC	5ec05285-4cbd-49c4-951b-86829da6f587	2025-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076856 application number: ANDA076856 ndc (product): 55154-7140
Dantrolene Sodium	DANTROLENE SODIUM	AvPAK	bd1ef298-2219-2a01-e053-2995a90abb08	2025-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076856 application number: ANDA076856 ndc (product): 50268-217
Dantrolene Sodium	DANTROLENE SODIUM	American Health Packaging	5162f162-8454-4c07-9670-682df7c30b0f	2024-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076856 application number: ANDA076856 ndc (product): 68084-300

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-4411	Dantrolene Sodium	Dantrolene Sodium	Impax Generics	ANDA	Current
0115-4411	Dantrolene Sodium	Dantrolene Sodium	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-4411	Dantrolene Sodium	Dantrolene Sodium	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-4411	Dantrolene Sodium	Dantrolene Sodium	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-4422	Dantrolene Sodium	Dantrolene Sodium	Impax Generics	ANDA	Current
0115-4422	Dantrolene Sodium	Dantrolene Sodium	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-4422	Dantrolene Sodium	Dantrolene Sodium	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-4422	Dantrolene Sodium	Dantrolene Sodium	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-4433	Dantrolene Sodium	Dantrolene Sodium	Impax Generics	ANDA	Current
0115-4433	Dantrolene Sodium	Dantrolene Sodium	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-4433	Dantrolene Sodium	Dantrolene Sodium	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-4433	Dantrolene Sodium	Dantrolene Sodium	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0904-7211	Dantrolene Sodium	Dantrolene Sodium	Major Pharmaceuticals	ANDA	Current
50268-217	Dantrolene Sodium	Dantrolene Sodium	AvPAK	ANDA	Current
50268-217	Dantrolene Sodium	Dantrolene Sodium	AvPAK	ANDA	Current
50268-217	Dantrolene Sodium	Dantrolene Sodium	AvPAK	ANDA	Current
55154-7140	Dantrolene Sodium	Dantrolene Sodium	Cardinal Health	ANDA	Current
55154-7140	Dantrolene Sodium	Dantrolene Sodium	Cardinal Health	ANDA	Current
55154-7140	Dantrolene Sodium	Dantrolene Sodium	Cardinal Health 107, LLC	ANDA	Current
55154-7140	Dantrolene Sodium	Dantrolene Sodium	Cardinal Health	ANDA	Current
68084-300	Dantrolene Sodium	Dantrolene Sodium	American Health Packaging	ANDA	Current
68084-300	Dantrolene Sodium	Dantrolene Sodium	American Health Packaging	ANDA	Current
68084-300	Dantrolene Sodium	Dantrolene Sodium	American Health Packaging	ANDA	Current
68084-300	Dantrolene Sodium	Dantrolene Sodium	American Health Packaging	ANDA	Current
68084-300	Dantrolene Sodium	Dantrolene Sodium	American Health Packaging	ANDA	Current
68151-1520	Dantrolene Sodium	Dantrolene Sodium	Carilion Materials Management	ANDA	Current