Application 076560

Type: ANDA
Sponsor: NEXGEN PHARMA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE	CAPSULE;ORAL	325MG;50MG;40MG;30MG	No	No
002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE	CAPSULE;ORAL	300MG;50MG;40MG;30MG	No	No

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

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
A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB		2004-06-10
A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB		2012-07-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076560-001	AB
A076560-002	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 3 · 84 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
2026-08-18 06:07:40	2026-07	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2012-07-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2012-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2012-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2012-07-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2012-07-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2012-07-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2012-07-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2012-07-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2012-07-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2012-07-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2012-07-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2012-07-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2012-07-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2012-07-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2012-07-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2012-07-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2012-07-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2012-07-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL		2012-07-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2012-07-19	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 75 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	A076560-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076560-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076560-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076560-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076560-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076560-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076560-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076560-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076560-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076560-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076560-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076560-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076560-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076560-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076560-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076560-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076560-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076560-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076560-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076560-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076560-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076560-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076560-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076560-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076560-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076560-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076560-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076560-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076560-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076560-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076560-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076560-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076560-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076560-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076560-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076560-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076560-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076560-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076560-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076560-001	AB	1	`782e0a99824c…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	Bryant Ranch Prepack	15a34df5-e48f-4570-9232-80e4093c4624	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076560 application number: ANDA076560 ndc (product): 71335-0194
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE	Actavis Pharma, Inc.	52321fe5-c001-4e2d-8149-3197ddc13764	2025-12-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076560 application number: ANDA076560 ndc (product): 0591-2641
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	Breckenridge Pharmaceutical, Inc.	d74db417-d2de-495b-bb75-46a83745603d	2024-09-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076560 application number: ANDA076560 ndc (product): 51991-073
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	Bryant Ranch Prepack	215e2a6f-ec32-4836-8fad-22c8b40ba1f1	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076560 application number: ANDA076560
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE	LGM PHARMA SOLUTIONS, LLC	180d20a5-78a8-4faa-98ad-3196cdd5663a	2021-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076560 application number: ANDA076560 ndc (product): 79739-6670
Fioricet with Codeine	BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE	Actavis Pharma, Inc.	df9801fc-03fe-41da-a6b3-0f76788217c9	2021-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076560 application number: ANDA076560 ndc (product): 52544-082

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-2641	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Actavis Pharma, Inc.	ANDA	Current
0591-2641	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Actavis Pharma, Inc.	ANDA	Current
0591-2641	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Actavis Pharma, Inc.	ANDA	Current
0591-2641	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Actavis Pharma, Inc.	ANDA	Current
0591-2641	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Actavis Pharma, Inc.	ANDA	Current
0722-6670	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Nexgen Pharma, Inc.	ANDA	Current
0722-6670	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Nexgen Pharma, Inc.	ANDA	Current
0722-6670	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Nexgen Pharma, Inc.	ANDA	Current
0722-7028	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Nexgen Pharma, Inc.	ANDA	Current
0722-7028	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Nexgen Pharma, Inc.	ANDA	Current
0722-7028	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Nexgen Pharma, Inc.	ANDA	Current
51991-073	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-073	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-073	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-073	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-073	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
52544-082	Fioricet with Codeine	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Actavis Pharma, Inc.	ANDA	Current
52544-082	Fioricet with Codeine	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Actavis Pharma, Inc.	ANDA	Current
52544-082	Fioricet with Codeine	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Actavis Pharma, Inc.	ANDA	Current
52544-082	Fioricet with Codeine	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Actavis Pharma, Inc.	ANDA	Current
68258-2012	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Dispensing Solutions, Inc.	ANDA	Current
71335-0194	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Bryant Ranch Prepack	ANDA	Current
71335-0194	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Bryant Ranch Prepack	ANDA	Current
71335-0194	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Bryant Ranch Prepack	ANDA	Current
79739-6670	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	LGM Pharma Solutions LLC	ANDA	Current
79739-6670	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	LGM Pharma Solutions, LLC	ANDA	Current
79739-7028	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	LGM Pharma Solutions, LLC	ANDA	Current
79739-7028	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	LGM Pharma Solutions, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76125	ORIG	2023-11-03