Application 090956

Type: ANDA
Sponsor: NEXGEN PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUTALBITAL AND ACETAMINOPHEN	ACETAMINOPHEN; BUTALBITAL	TABLET;ORAL	300MG;50MG	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A090956-001	BUTALBITAL AND ACETAMINOPHEN	ACETAMINOPHEN; BUTALBITAL	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090956-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A090956-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090956-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090956-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090956-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090956-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090956-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090956-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090956-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090956-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090956-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090956-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090956-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090956-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090956-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090956-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090956-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090956-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090956-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090956-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090956-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090956-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090956-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090956-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090956-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090956-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090956-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090956-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090956-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090956-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090956-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090956-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090956-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090956-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090956-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090956-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090956-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090956-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090956-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090956-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090956-001	AA	1	`f41ea6bd6efb…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Butalbital and Acetaminophen	BUTALBITAL AND ACETAMINOPHEN TABLETS	Oceanside Pharmaceuticals	d2213ffd-18f6-45f5-9af7-690a977562c4	2020-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090956 application number: ANDA090956 ndc (product): 68682-306

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0095-3000	BUPAP	Butalbital and Acetaminophen Tablets	Bausch Health US, LLC	ANDA	Current
0095-3000	BUPAP	Butalbital and Acetaminophen Tablets	ECR Pharmaceuticals	ANDA	Current
0095-3000	BUPAP	Butalbital and Acetaminophen Tablets	Bausch Health Americas Inc.	ANDA	Current
0095-3000	BUPAP	Butalbital and Acetaminophen Tablets	Bausch Health US, LLC	ANDA	Current
0095-3000	BUPAP	Butalbital and Acetaminophen Tablets	Bausch Health US, LLC	ANDA	Current
0722-7075	Butalbital and Acetaminophen	Butalbital and Acetaminophen	Nexgen Pharma, Inc.	ANDA	Current
0722-7075	Butalbital and Acetaminophen	Butalbital and Acetaminophen	Nexgen Pharma, Inc.	ANDA	Current
68682-306	Butalbital and Acetaminophen	Butalbital and Acetaminophen tablets	Oceanside Pharmaceuticals	ANDA	Current
68682-306	Butalbital and Acetaminophen	Butalbital and Acetaminophen tablets	Oceanside Pharmaceuticals	ANDA	Current
68682-306	Butalbital and Acetaminophen	Butalbital and Acetaminophen tablets	Oceanside Pharmaceuticals	ANDA	Current
68682-306	Butalbital and Acetaminophen	Butalbital and Acetaminophen tablets	Oceanside Pharmaceuticals	ANDA	Current
79739-7075	Butalbital and Acetaminophen	Butalbital and Acetaminophen	LGM Pharma Solutions, LLC	ANDA	Current