Application 076686

Type: ANDA
Sponsor: ELITE LABS INC

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
A076686-001	DANTROLENE SODIUM	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-10-24
A076686-002	DANTROLENE SODIUM	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-10-24
A076686-003	DANTROLENE SODIUM	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-10-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076686-001	AB
A076686-002	AB
A076686-003	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	A076686-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076686-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076686-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-10-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076686-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076686-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076686-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-10-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076686-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076686-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076686-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-10-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076686-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076686-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076686-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-10-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076686-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076686-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076686-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-10-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076686-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076686-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076686-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-10-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076686-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-10-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076686-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-10-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076686-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-10-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076686-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-10-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076686-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-10-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076686-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-10-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076686-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-10-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076686-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-10-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076686-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-10-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076686-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-10-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076686-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-10-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076686-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-10-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076686-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-10-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076686-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-10-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076686-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-10-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076686-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-10-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076686-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-10-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076686-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-10-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076686-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-10-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076686-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-10-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076686-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-10-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076686-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-10-24	`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	A076686-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076686-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076686-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076686-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076686-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076686-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076686-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076686-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076686-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076686-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076686-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076686-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076686-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076686-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076686-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076686-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076686-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076686-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076686-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076686-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076686-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076686-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076686-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076686-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076686-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076686-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076686-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076686-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076686-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076686-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076686-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076686-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076686-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076686-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076686-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076686-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076686-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076686-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076686-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076686-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dantrolene Sodium	DANTROLENE SODIUM	Bryant Ranch Prepack	e432a760-40b8-4efa-af2b-18e027ac5ae4	2024-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076686 application number: ANDA076686
Dantrolene Sodium	DANTROLENE SODIUM	Bryant Ranch Prepack	dbf78d48-71a6-4a9b-bf31-e710b78944f2	2024-08-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076686 application number: ANDA076686
Dantrolene Sodium	DANTROLENE SODIUM	Bryant Ranch Prepack	bd218ddb-c133-438c-9545-321ae4b52440	2024-08-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076686 application number: ANDA076686
Dantrolene Sodium	DANTROLENE SODIUM	Elite Laboratories, Inc.	e637fb20-6a17-4522-810a-990bf1409732	2019-12-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076686 application number: ANDA076686 ndc (product): 64850-841 ndc (product): 64850-840 ndc (product): 64850-842

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0527-3219	Dantrolene Sodium	dantrolene sodium	Lannett Company, Inc.	ANDA	Current
0527-3220	Dantrolene Sodium	dantrolene sodium	Lannett Company, Inc.	ANDA	Current
0527-3221	Dantrolene Sodium	dantrolene sodium	Lannett Company, Inc.	ANDA	Current
64850-840	Dantrolene Sodium	dantrolene sodium	Elite Laboratories, Inc.	ANDA	Current
64850-841	Dantrolene Sodium	dantrolene sodium	Elite Laboratories, Inc.	ANDA	Current
64850-842	Dantrolene Sodium	dantrolene sodium	Elite Laboratories, Inc.	ANDA	Current