Application 086996

Type: ANDA
Sponsor: LANNETT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	LANORINAL	ASPIRIN; BUTALBITAL; CAFFEINE	CAPSULE;ORAL	325MG;50MG;40MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A086996-002	LANORINAL	ASPIRIN; BUTALBITAL; CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1985-10-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A086996-002	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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1985-10-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1985-10-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1985-10-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1985-10-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1985-10-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1985-10-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1985-10-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1985-10-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1985-10-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1985-10-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1985-10-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1985-10-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1985-10-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1985-10-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1985-10-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA		1985-10-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA		1985-10-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA		1985-10-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA		1985-10-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA		1985-10-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA		1985-10-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA		1985-10-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA		1985-10-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA		1985-10-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA		1985-10-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA		1985-10-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA		1985-10-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1985-10-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1985-10-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1985-10-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1985-10-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1985-10-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1985-10-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1985-10-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1985-10-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1985-10-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1985-10-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1985-10-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1985-10-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086996-002	LANORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1985-10-11	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A086996-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086996-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086996-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086996-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086996-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086996-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086996-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086996-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086996-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086996-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086996-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086996-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086996-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086996-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086996-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086996-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086996-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086996-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086996-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086996-002	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086996-002	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086996-002	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086996-002	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086996-002	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086996-002	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086996-002	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086996-002	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086996-002	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086996-002	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086996-002	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086996-002	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086996-002	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086996-002	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086996-002	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086996-002	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086996-002	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086996-002	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086996-002	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086996-002	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086996-002	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 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
butalbital, aspirin, and caffeine	BUTALBITAL, ASPIRIN, AND CAFFEINE	Chartwell RX, LLC	e69d8bb1-ba09-42e2-8372-7f5e0a906174	2025-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086996 application number: ANDA086996 ndc (product): 62135-433
Butalbital, aspirin, and caffeine	BUTALBITAL, ASPIRIN, AND CAFFEINE	Sandoz Inc	0e5e3842-fc6c-4a24-8e5c-522701f7c291	2024-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086996 application number: ANDA086996
Butalbital, aspirin, and caffeine	BUTALBITAL, ASPIRIN, AND CAFFEINE	Lannett Company, Inc.	ba60b130-33cd-4db9-92a7-2cab8ded0737	2021-05-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086996 application number: ANDA086996 ndc (product): 0527-1552

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0527-1552	Butalbital, aspirin, and caffeine	Butalbital, aspirin, and caffeine	Lannett Company, Inc.	ANDA	Current
0527-1552	Butalbital, aspirin, and caffeine	Butalbital, aspirin, and caffeine	Lannett Company, Inc.	ANDA	Current
0527-1552	Butalbital, aspirin, and caffeine	Butalbital, aspirin, and caffeine	Lannett Company, Inc.	ANDA	Current
0527-1552	Butalbital, aspirin, and caffeine	Butalbital, aspirin, and caffeine	Lannett Company, Inc.	ANDA	Current
0527-1552	Butalbital, aspirin, and caffeine	Butalbital, aspirin, and caffeine	Lannett Company, Inc.	ANDA	Current
50090-1580	Butalbital, aspirin, and caffeine	Butalbital, aspirin, and caffeine	A-S Medication Solutions	ANDA	Current
50090-1580	Butalbital, aspirin, and caffeine	Butalbital, aspirin, and caffeine	A-S Medication Solutions	ANDA	Current
50090-1580	Butalbital, aspirin, and caffeine	Butalbital, aspirin, and caffeine	A-S Medication Solutions	ANDA	Current
55700-129	Butalbital, aspirin, and caffeine	Butalbital, aspirin, and caffeine	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
62135-433	butalbital, aspirin, and caffeine	butalbital, aspirin, and caffeine	Chartwell RX, LLC	ANDA	Current