Application 040511

Type: ANDA
Sponsor: VINTAGE PHARMS

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	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
A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	325MG;50MG;40MG	TABLET / ORAL			2003-08-27

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	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL			2003-08-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL			2003-08-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040511-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040511-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040511-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040511-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040511-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040511-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040511-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040511-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040511-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040511-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040511-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040511-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040511-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040511-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040511-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040511-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040511-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040511-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040511-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040511-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040511-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040511-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040511-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040511-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040511-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040511-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040511-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040511-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040511-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040511-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040511-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040511-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040511-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040511-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040511-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040511-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040511-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040511-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040511-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040511-001	AA	1	`cb3db0bc1861…`

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 2 of 2 · 37 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	Dr. Reddy's Labratories Inc.	69df02fa-c842-48dc-7ac6-5967b7dc30de	2024-08-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: butalbital, acetaminophen and caffeine
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	QUAGEN PHARMACEUTICALS LLC	8438f08f-a32a-4180-9030-e0fd5da4be30	2024-05-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	QUAGEN PHARMACEUTICALS LLC	24813ec6-0111-4782-9182-a2b93501a2bc	2024-05-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Butalbital, Acetaminophen and Caffeine	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Bryant Ranch Prepack	e9dffed5-d615-4e63-9860-c0f6f23848a1	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Butalbital, Acetaminophen and Caffeine
Butalbital, Acetaminophen and Caffeine	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	KVK-Tech, Inc.	7f9c4668-4f4a-453b-b2fa-a6fed903ddfa	2024-02-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Butalbital, Acetaminophen and Caffeine
butalbital, acetaminophen and caffeine	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Bryant Ranch Prepack	6a593fc7-49b0-4910-8a0c-5e718e5ff45b	2024-01-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: butalbital, acetaminophen and caffeine
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Seton Pharmaceuticals LLC	3c5cefe3-c84e-4380-97f3-78e3fe92543a	2024-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
butalbital, acetaminophen and caffeine	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Mikart, LLC	a26775c2-cafb-4b13-99ac-d4e8248265fb	2024-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: butalbital, acetaminophen and caffeine
Butalbital, Acetaminophen and Caffeine	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Granules Pharmaceuticals Inc.	2407efce-b77e-4072-bc4b-62c789d01e1a	2023-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Butalbital, Acetaminophen and Caffeine
Butalbital, Acetaminophen and Caffeine	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Bryant Ranch Prepack	b94ab2bc-6ef3-4a64-ba05-a0a4e37794fa	2023-11-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Butalbital, Acetaminophen and Caffeine
Butalbital, Acetaminophen and Caffeine	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Bryant Ranch Prepack	6e28cc29-a85a-44d0-9c5b-bd0934ece64d	2023-11-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Butalbital, Acetaminophen and Caffeine
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	QUAGEN PHARMACEUTICALS LLC	5f3c7457-6670-4a0d-bdff-c3e0fe91b7c6	2023-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
butalbital, acetaminophen and caffeine	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Bryant Ranch Prepack	3875c01b-7cd6-4bed-8d4e-c580c5540860	2023-04-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: butalbital, acetaminophen and caffeine
Butalbital, Acetaminophen and Caffeine	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Golden State Medical Supply, Inc.	ee131bce-863b-b5a1-e053-2a95a90afc79	2023-03-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Butalbital, Acetaminophen and Caffeine
Butalbital, Acetaminophen and Caffeine	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Granules Pharmaceuticals Inc.	74e27dab-9790-47e4-b4f1-3b9df4bce184	2023-01-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Butalbital, Acetaminophen and Caffeine
butalbital, acetaminophen and caffeine	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Proficient Rx LP	1bde13a5-cdd4-4bc2-8aeb-32e4dc157293	2021-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: butalbital, acetaminophen and caffeine
butalbital, acetaminophen and caffeine	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Lannett Company, Inc.	c1107153-494b-4068-8500-96bc241187a5	2019-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: butalbital, acetaminophen and caffeine

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0603-2544	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Par Pharmaceutical, Inc.	ANDA	Current
0603-2544	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Par Pharmaceutical	ANDA	Current
0603-2544	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Par Pharmaceutical	ANDA	Current
55154-7147	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Cardinal Health 107, LLC	ANDA	Current
55154-7147	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Cardinal Health	ANDA	Current
55154-7147	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Cardinal Health	ANDA	Current
55289-879	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-879	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
60687-672	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	American Health Packaging	ANDA	Current
60687-672	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	American Health Packaging	ANDA	Current
63629-1774	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Bryant Ranch Prepack	ANDA	Current
63629-2140	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Bryant Ranch Prepack	ANDA	Current
63629-2140	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Bryant Ranch Prepack	ANDA	Current
63629-2140	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Bryant Ranch Prepack	ANDA	Current
63629-2140	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Bryant Ranch Prepack	ANDA	Current
63629-2151	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Bryant Ranch Prepack	ANDA	Current
63629-2151	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Bryant Ranch Prepack	ANDA	Current
63629-2151	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Bryant Ranch Prepack	ANDA	Current
63629-2151	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Bryant Ranch Prepack	ANDA	Current
64380-157	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Strides Pharma Science Limited	ANDA	Current
64380-157	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Strides Pharma Science Limited	ANDA	Current
64380-157	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Strides Pharma Science Limited	ANDA	Current
64380-157	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Strides Pharma Science Limited	ANDA	Current
67296-0718	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen and Caffeine	RedPharm Drug Inc.	ANDA	Current
67544-394	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
68084-396	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	American Health Packaging	ANDA	Current
68084-396	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen and Caffeine	American Health Packaging	ANDA	Current
68084-396	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen and Caffeine	American Health Packaging	ANDA	Current
68084-396	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen and Caffeine	American Health Packaging	ANDA	Current
68084-396	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen and Caffeine	American Health Packaging	ANDA	Current
68151-1313	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Carilion Materials Management	ANDA	Current
71335-1977	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Bryant Ranch Prepack	ANDA	Current
71335-1977	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Bryant Ranch Prepack	ANDA	Current