Application 214088

Type: ANDA
Sponsor: HAVIX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUTALBITAL AND ACETAMINOPHEN	ACETAMINOPHEN; BUTALBITAL	TABLET;ORAL	25MG;325MG	No	No
002	BUTALBITAL AND ACETAMINOPHEN	ACETAMINOPHEN; BUTALBITAL	TABLET;ORAL	50MG;325MG	No	No
003	BUTALBITAL AND ACETAMINOPHEN	ACETAMINOPHEN; BUTALBITAL	TABLET;ORAL	50MG;300MG	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
A214088-001	BUTALBITAL AND ACETAMINOPHEN	ACETAMINOPHEN; BUTALBITAL	300MG;50MG	TABLET / ORAL	AA	2022-04-07
A214088-002	BUTALBITAL AND ACETAMINOPHEN	ACETAMINOPHEN; BUTALBITAL	325MG;25MG	TABLET / ORAL	AA	2022-04-07
A214088-003	BUTALBITAL AND ACETAMINOPHEN	ACETAMINOPHEN; BUTALBITAL	325MG;50MG	TABLET / ORAL	AA	2022-04-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214088-001	AA
A214088-002	AA
A214088-003	AA

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 · 87 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	A214088-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	2022-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214088-002	BUTALBITAL AND ACETAMINOPHEN	325MG;25MG	TABLET / ORAL	AA	2022-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214088-003	BUTALBITAL AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	AA	2022-04-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214088-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	2022-04-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214088-002	BUTALBITAL AND ACETAMINOPHEN	325MG;25MG	TABLET / ORAL	AA	2022-04-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214088-003	BUTALBITAL AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	AA	2022-04-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214088-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	2022-04-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214088-002	BUTALBITAL AND ACETAMINOPHEN	325MG;25MG	TABLET / ORAL	AA	2022-04-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214088-003	BUTALBITAL AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	AA	2022-04-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214088-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	2022-04-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214088-002	BUTALBITAL AND ACETAMINOPHEN	325MG;25MG	TABLET / ORAL	AA	2022-04-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214088-003	BUTALBITAL AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	AA	2022-04-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214088-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	2022-04-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214088-002	BUTALBITAL AND ACETAMINOPHEN	325MG;25MG	TABLET / ORAL	AA	2022-04-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214088-003	BUTALBITAL AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	AA	2022-04-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214088-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	2022-04-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214088-002	BUTALBITAL AND ACETAMINOPHEN	325MG;25MG	TABLET / ORAL	AA	2022-04-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214088-003	BUTALBITAL AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	AA	2022-04-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214088-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	2022-04-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214088-002	BUTALBITAL AND ACETAMINOPHEN	325MG;25MG	TABLET / ORAL	AA	2022-04-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214088-003	BUTALBITAL AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	AA	2022-04-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214088-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	2022-04-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214088-002	BUTALBITAL AND ACETAMINOPHEN	325MG;25MG	TABLET / ORAL	AA	2022-04-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214088-003	BUTALBITAL AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	AA	2022-04-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214088-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	2022-04-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214088-002	BUTALBITAL AND ACETAMINOPHEN	325MG;25MG	TABLET / ORAL	AA	2022-04-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214088-003	BUTALBITAL AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	AA	2022-04-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214088-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	2022-04-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214088-002	BUTALBITAL AND ACETAMINOPHEN	325MG;25MG	TABLET / ORAL	AA	2022-04-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214088-003	BUTALBITAL AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	AA	2022-04-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214088-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	2022-04-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214088-002	BUTALBITAL AND ACETAMINOPHEN	325MG;25MG	TABLET / ORAL	AA	2022-04-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214088-003	BUTALBITAL AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	AA	2022-04-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214088-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	2022-04-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214088-002	BUTALBITAL AND ACETAMINOPHEN	325MG;25MG	TABLET / ORAL	AA	2022-04-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214088-003	BUTALBITAL AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	AA	2022-04-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214088-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	2022-04-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214088-002	BUTALBITAL AND ACETAMINOPHEN	325MG;25MG	TABLET / ORAL	AA	2022-04-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214088-003	BUTALBITAL AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	AA	2022-04-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214088-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	2022-04-07	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 87 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	A214088-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214088-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214088-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214088-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214088-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214088-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214088-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214088-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214088-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214088-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214088-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214088-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214088-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214088-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214088-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214088-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214088-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214088-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214088-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214088-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214088-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214088-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214088-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214088-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214088-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214088-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214088-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214088-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214088-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214088-003	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214088-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214088-002	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214088-003	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214088-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214088-002	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214088-003	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214088-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214088-002	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214088-003	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214088-001	AA	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BUTALBITAL AND ACETAMINOPHEN	BUTALBITAL AND ACETAMINOPHEN	Amici Pharma, Inc.	3280501f-928a-4112-803d-fb9771c86547	2026-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214088 application number: ANDA214088
BUTALBITAL AND ACETAMINOPHEN	BUTALBITAL AND ACETAMINOPHEN	Burel Pharmaceuticals, LLC	0a8a6a16-b23f-45d2-b5d4-540264e74d14	2024-10-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214088 application number: ANDA214088 ndc (product): 35573-455 ndc (product): 35573-456

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
35573-455	BUTALBITAL AND ACETAMINOPHEN	butalbital and acetaminophen	Burel Pharmaceuticals, LLC	ANDA	Current
35573-455	BUTALBITAL AND ACETAMINOPHEN	butalbital and acetaminophen	Burel Pharmaceuticals, LLC	ANDA	Current
35573-456	BUTALBITAL AND ACETAMINOPHEN	butalbital and acetaminophen	Burel Pharmaceuticals, LLC	ANDA	Current
35573-456	BUTALBITAL AND ACETAMINOPHEN	butalbital and acetaminophen	Burel Pharmaceuticals, LLC	ANDA	Current