Application 214087

Type: ANDA
Sponsor: HAVIX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	CAPSULE;ORAL	300MG;50MG;40MG	No	No
002	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	CAPSULE;ORAL	325MG;50MG;40MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A214087-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA		2021-08-13
A214087-002	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA		2021-08-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A214087-001	AA
A214087-002	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 2 · 66 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	A214087-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214087-002	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214087-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214087-002	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214087-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214087-002	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214087-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214087-002	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214087-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214087-002	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214087-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214087-002	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214087-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214087-002	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214087-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214087-002	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214087-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214087-002	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214087-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214087-002	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214087-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214087-002	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214087-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214087-002	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214087-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214087-002	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214087-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214087-002	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214087-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214087-002	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214087-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214087-002	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214087-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214087-002	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214087-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214087-002	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214087-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A214087-002	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214087-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214087-002	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	2021-08-13	`6a51e52b5d6a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 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	A214087-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214087-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214087-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214087-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214087-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214087-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214087-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214087-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214087-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214087-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214087-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214087-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214087-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214087-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214087-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214087-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214087-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214087-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214087-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214087-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214087-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214087-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214087-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214087-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214087-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214087-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214087-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214087-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214087-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214087-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214087-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214087-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214087-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214087-002	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214087-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214087-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214087-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A214087-002	AA	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214087-001	AA	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214087-002	AA	1	`6a51e52b5d6a…`

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
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Amici Pharma, Inc.	fb12459c-82f8-43d2-8c05-a4b6d4a3e948	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214087 application number: ANDA214087
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Advanced Rx of Tennessee, LLC	2e20e0ee-dd73-6287-e063-6294a90a03b1	2025-02-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214087 application number: ANDA214087
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	SOLCO HEALTHCARE US, LLC	5c9c3407-212a-4ae9-a574-2b0c53f3c5eb	2024-09-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214087 application number: ANDA214087
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Seton Pharmaceuticals LLC	3c5cefe3-c84e-4380-97f3-78e3fe92543a	2024-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214087 application number: ANDA214087 ndc (product): 13925-535 ndc (product): 13925-536

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
13925-535	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	butalbital, acetaminophen and caffeine	Seton Pharmaceuticals LLC	ANDA	Current
13925-535	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	butalbital, acetaminophen and caffeine	Seton Pharmaceuticals LLC	ANDA	Current
13925-536	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	butalbital, acetaminophen and caffeine	Seton Pharmaceuticals LLC	ANDA	Current
13925-536	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	butalbital, acetaminophen and caffeine	Seton Pharmaceuticals LLC	ANDA	Current