Application 089007

Type: ANDA
Sponsor: MAYNE PHARMA INC

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A089007-001	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 2 of 2 · 44 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
2022-10-28 04:53 UTC	2022-10	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A089007-001	AA	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A089007-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A089007-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089007-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089007-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089007-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089007-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089007-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089007-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089007-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089007-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089007-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089007-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089007-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089007-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089007-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089007-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089007-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089007-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089007-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089007-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089007-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089007-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089007-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089007-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089007-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089007-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089007-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089007-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089007-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089007-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089007-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089007-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089007-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089007-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089007-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089007-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089007-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089007-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089007-001	AA	1	`3a93d1ddd44b…`

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, 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	Exact identifier application applno (ANDA): 089007 application number: ANDA089007

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 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51862-179	butalbital, acetaminophen and caffeine	butalbital, acetaminophen and caffeine	Mayne Pharma	ANDA	Current
51862-179	butalbital, acetaminophen and caffeine	butalbital, acetaminophen and caffeine	Mayne Pharma	ANDA	Current
51862-179	butalbital, acetaminophen and caffeine	butalbital, acetaminophen and caffeine	Mayne Pharma	ANDA	Current
68308-219	Esgic	butalbital, acetaminophen and caffeine	Mayne Pharma Inc.	ANDA	Current
68308-219	Esgic	butalbital, acetaminophen and caffeine	Mayne Pharma Inc.	ANDA	Current
68308-219	Esgic	butalbital, acetaminophen and caffeine	Mayne Pharma Inc.	ANDA	Current
68308-554	Zebutal	butalbital, acetaminophen and caffeine	Mayne Pharma Inc.	ANDA	Current
68308-554	Zebutal	butalbital, acetaminophen and caffeine	Mayne Pharma Inc.	ANDA	Current
68308-554	Zebutal	butalbital, acetaminophen and caffeine	Mayne Pharma Inc.	ANDA	Current