Application 211106

Type: ANDA
Sponsor: ABHAI LLC

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2018-09-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211106-001	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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2018-09-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-09-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-09-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-09-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-09-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-09-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-09-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-09-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-09-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-09-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-09-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-09-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-09-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-09-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-09-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-09-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-09-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-09-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-09-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-09-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-09-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-09-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-09-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-09-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-09-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-09-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-09-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-09-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-09-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-09-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-09-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-09-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-09-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-09-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-09-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-09-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-09-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-09-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-09-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-09-26	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A211106-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211106-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211106-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211106-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211106-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211106-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211106-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211106-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211106-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211106-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211106-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211106-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211106-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211106-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211106-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211106-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211106-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211106-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211106-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211106-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211106-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211106-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211106-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211106-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211106-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211106-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211106-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211106-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211106-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211106-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211106-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211106-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211106-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211106-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211106-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211106-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211106-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211106-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211106-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211106-001	AA	1	`e64feba35796…`

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
Butalbital, Acetaminophen and Caffeine	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Preferred Pharmaceuticals Inc.	65fa9aca-ef3d-4bc6-a107-72e6eb5ce224	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211106 application number: ANDA211106
Butalbital, Acetaminophen and Caffeine	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Redpharm Drug	4727e806-102a-3a28-e063-6294a90ab6e9	2025-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211106 application number: ANDA211106
Butalbital, Acetaminophen and Caffeine	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	A-S Medication Solutions	21a148d1-b242-4414-82b2-cb78387d7d0f	2025-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211106 application number: ANDA211106
Butalbital, Acetaminophen and Caffeine	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Bryant Ranch Prepack	e9dffed5-d615-4e63-9860-c0f6f23848a1	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211106 application number: ANDA211106 ndc (product): 71335-9603
Butalbital, Acetaminophen and Caffeine	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	KVK-Tech, Inc.	7f9c4668-4f4a-453b-b2fa-a6fed903ddfa	2024-02-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211106 application number: ANDA211106 ndc (product): 10702-253

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10702-253	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen and Caffeine	KVK-Tech, Inc.	ANDA	Current
10702-253	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen and Caffeine	KVK-Tech, Inc.	ANDA	Current
71335-9603	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen and Caffeine	Bryant Ranch Prepack	ANDA	Current