Application 203484

Type: ANDA
Sponsor: LARKEN LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALLZITAL	ACETAMINOPHEN; BUTALBITAL	TABLET;ORAL	325MG;25MG	No	Yes
002	BUTALBITAL AND ACETAMINOPHEN	ACETAMINOPHEN; BUTALBITAL	TABLET;ORAL	325MG;50MG	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
A203484-001	ALLZITAL	ACETAMINOPHEN; BUTALBITAL	325MG;25MG	TABLET / ORAL	AA	RS	2015-12-04
A203484-002	BUTALBITAL AND ACETAMINOPHEN	ACETAMINOPHEN; BUTALBITAL	325MG;50MG	TABLET / ORAL	AA		2015-12-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203484-001	AA
A203484-002	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 3 · 84 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	A203484-001	ALLZITAL	325MG;25MG	TABLET / ORAL	AA	RS	2015-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203484-002	BUTALBITAL AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	AA		2015-12-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203484-001	ALLZITAL	325MG;25MG	TABLET / ORAL	AA	RS	2015-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203484-002	BUTALBITAL AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	AA		2015-12-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203484-001	ALLZITAL	325MG;25MG	TABLET / ORAL	AA	RS	2015-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203484-002	BUTALBITAL AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	AA		2015-12-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203484-001	ALLZITAL	325MG;25MG	TABLET / ORAL	AA	RS	2015-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203484-002	BUTALBITAL AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	AA		2015-12-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203484-001	ALLZITAL	325MG;25MG	TABLET / ORAL	AA	RS	2015-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203484-002	BUTALBITAL AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	AA		2015-12-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203484-001	ALLZITAL	325MG;25MG	TABLET / ORAL	AA	RS	2015-12-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203484-002	BUTALBITAL AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	AA		2015-12-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203484-001	ALLZITAL	325MG;25MG	TABLET / ORAL	AA	RS	2015-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203484-002	BUTALBITAL AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	AA		2015-12-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203484-001	ALLZITAL	325MG;25MG	TABLET / ORAL	AA	RS	2015-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203484-002	BUTALBITAL AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	AA		2015-12-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203484-001	ALLZITAL	325MG;25MG	TABLET / ORAL	AA	RS	2015-12-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203484-002	BUTALBITAL AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	AA		2015-12-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203484-001	ALLZITAL	325MG;25MG	TABLET / ORAL	AA	RS	2015-12-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203484-002	BUTALBITAL AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	AA		2015-12-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203484-001	ALLZITAL	325MG;25MG	TABLET / ORAL	AA	RS	2015-12-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203484-002	BUTALBITAL AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	AA		2015-12-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203484-001	ALLZITAL	325MG;25MG	TABLET / ORAL	AA	RS	2015-12-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203484-002	BUTALBITAL AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	AA		2015-12-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203484-001	ALLZITAL	325MG;25MG	TABLET / ORAL	AA	RS	2015-12-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203484-002	BUTALBITAL AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	AA		2015-12-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203484-001	ALLZITAL	325MG;25MG	TABLET / ORAL	AA	RS	2015-12-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203484-002	BUTALBITAL AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	AA		2015-12-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203484-001	ALLZITAL	325MG;25MG	TABLET / ORAL	AA	RS	2015-12-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203484-002	BUTALBITAL AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	AA		2015-12-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203484-001	ALLZITAL	325MG;25MG	TABLET / ORAL	AA	RS	2015-12-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203484-002	BUTALBITAL AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	AA		2015-12-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203484-001	ALLZITAL	325MG;25MG	TABLET / ORAL		RS	2015-12-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203484-002	BUTALBITAL AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	AA		2015-12-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203484-001	ALLZITAL	325MG;25MG	TABLET / ORAL		RS	2015-12-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203484-002	BUTALBITAL AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	AA		2015-12-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203484-001	ALLZITAL	325MG;25MG	TABLET / ORAL		RS	2015-12-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203484-002	BUTALBITAL AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	AA		2015-12-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203484-001	ALLZITAL	325MG;25MG	TABLET / ORAL		RS	2015-12-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203484-002	BUTALBITAL AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	AA		2015-12-04	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 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	A203484-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203484-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203484-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203484-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203484-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203484-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203484-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203484-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203484-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203484-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203484-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203484-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203484-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203484-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203484-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203484-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203484-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203484-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203484-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203484-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203484-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203484-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203484-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203484-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203484-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203484-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203484-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203484-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203484-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203484-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203484-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203484-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203484-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203484-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203484-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203484-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203484-002	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203484-002	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203484-002	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203484-002	AA	1	`8869cabd3fbd…`

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	Larken Laboratories, Inc.	326c83fc-afed-45ad-9c87-f47968fa1d2a	2025-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203484 application number: ANDA203484 ndc (product): 68047-721 ndc (product): 68047-753 ndc (product): 68047-752

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
54879-026	Butalbital And Acetaminophen	butalbital and acetaminophen	STI Pharma LLC	ANDA	Current
68047-721	Butalbital And Acetaminophen	butalbital and acetaminophen	Larken Laboratories, Inc.	ANDA	Current
68047-721	Butalbital And Acetaminophen	butalbital and acetaminophen	Larken Laboratories, Inc.	ANDA	Current
68047-721	Butalbital And Acetaminophen	butalbital and acetaminophen	Larken Laboratories, Inc.	ANDA	Current
68047-721	Butalbital And Acetaminophen	butalbital and acetaminophen	Larken Laboratories, Inc.	ANDA	Current
68047-721	Butalbital And Acetaminophen	butalbital and acetaminophen	Larken Laboratories, Inc.	ANDA	Current
68047-721	Butalbital And Acetaminophen	butalbital and acetaminophen	Larken Laboratories, Inc.	ANDA	Current
68047-721	Butalbital And Acetaminophen	butalbital and acetaminophen	Larken Laboratories, Inc.	ANDA	Current
68047-721	Butalbital And Acetaminophen	butalbital and acetaminophen	Larken Laboratories, Inc.	ANDA	Current
68047-722	butalbital and acetaminophen	butalbital and acetaminophen	Larken Laboratories, Inc.	ANDA	Current
68047-722	Butalbital and Acetaminophen	butalbital and acetaminophen	Larken Laboratories, Inc.	ANDA	Current
68047-722	butalbital and acetaminophen	butalbital and acetaminophen	Larken Laboratories, Inc.	ANDA	Current
68047-722	butalbital and acetaminophen	butalbital and acetaminophen	Larken Laboratories, Inc.	ANDA	Current
68047-722	butalbital and acetaminophen	butalbital and acetaminophen	Larken Laboratories, Inc.	ANDA	Current
68047-722	butalbital and acetaminophen	butalbital and acetaminophen	Larken Laboratories, Inc.	ANDA	Current
68047-752	Allzital	butalbital and acetaminophen	Larken Laboratories, Inc.	ANDA	Current
68047-752	ALLZITAL	butalbital and acetaminophen	Larken Laboratories, Inc.	ANDA	Current
68047-752	ALLZITAL	butalbital and acetaminophen	Larken Laboratories, Inc.	ANDA	Current
68047-752	ALLZITAL	butalbital and acetaminophen	Larken Laboratories, Inc.	ANDA	Current
68047-752	ALLZITAL	butalbital and acetaminophen	Larken Laboratories, Inc.	ANDA	Current
68047-752	ALLZITAL	butalbital and acetaminophen	Larken Laboratories, Inc.	ANDA	Current
68047-752	ALLZITAL	butalbital and acetaminophen	Larken Laboratories, Inc.	ANDA	Current
68047-753	Butalbital and Acetaminophen	butalbital and acetaminophen	Larken Laboratories, Inc.	ANDA	Current
70362-722	ALLZITAL	butalbital and acetaminophen	Skylar Laboratories, LLC	ANDA	Current
70362-722	ALLZITAL	butalbital and acetaminophen	Skylar Laboratories, LLC	ANDA	Current
70569-150	ALLZITAL	butalbital and acetaminophen	Phlight Pharma, LLC	ANDA	Current
70569-150	ALLZITAL	butalbital and acetaminophen	Phlight Pharma, LLC	ANDA	Current
70569-150	ALLZITAL	butalbital and acetaminophen	Phlight Pharma, LLC	ANDA	Current
70569-150	ALLZITAL	butalbital and acetaminophen	Phlight Pharma, LLC	ANDA	Current
71993-301	Butalbital and Acetaminophen	Butalbital and Acetaminophen	Atland Pharmaceuticals, LLC	ANDA	Current
73159-003	Butalbital and Acetaminophen	butalbital and acetaminophen	Lacer Pharma, LLC	ANDA	Current