Application 085864

Type: ANDA
Sponsor: UCB INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	TABLET;ORAL	10MG	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
A085864-001	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL		Approved before 1982

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	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A085864-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`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 6 · 110 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Northwind Health Company, LLC	471b99ac-395c-3137-e063-6394a90af18d	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amitriptyline Hydrochloride generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	35aa7ab3-321a-97f7-e063-6294a90a91e2	2026-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amitriptyline Hydrochloride generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	16364b31-4b8b-481a-a553-e8974c0e557c	2026-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amitriptyline Hydrochloride generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	e3dd745a-57f5-4925-e053-2995a90a43c0	2026-06-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amitriptyline Hydrochloride generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	5dc3c2d7-60a2-4754-be33-1f9401c925a4	2026-06-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amitriptyline Hydrochloride generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	9ced0126-d597-48fb-96d3-577333760048	2026-06-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amitriptyline Hydrochloride generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	1b2d2bb8-78c8-7e8e-e063-6294a90a2576	2026-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amitriptyline Hydrochloride generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	ce87013b-bf4a-47d1-9808-7cb8290feb23	2026-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amitriptyline Hydrochloride generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Coupler LLC	5070fa18-ecc9-de14-e063-6394a90a372e	2026-04-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amitriptyline Hydrochloride generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Coupler LLC	50375dab-97fe-8c84-e063-6394a90a60b2	2026-04-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amitriptyline Hydrochloride generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Coupler LLC	500f239c-0460-a22b-e063-6294a90a1ba6	2026-04-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amitriptyline Hydrochloride generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	abf6a3f5-0df9-4b23-995d-63b973ef80c1	2026-04-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amitriptyline Hydrochloride generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	c66e9088-4f34-4b97-971e-5272b45cfc97	2026-04-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amitriptyline Hydrochloride generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	9f9d6495-47ff-4dcf-9643-ebd5cd7499cb	2026-04-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amitriptyline Hydrochloride generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Lifestar Pharma LLC	67e31675-1da2-4acf-84ac-77522b02f0b9	2026-04-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amitriptyline Hydrochloride generic name: AMITRIPTYLINE HYDROCHLORIDE
AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	Aurobindo Pharma Limited	8085a37f-3c76-4f74-aab3-9a929a7eb1c2	2026-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: AMITRIPTYLINE HYDROCHLORIDE generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	53f4f83c-4bfd-43d6-9bb8-82c21ed2864f	2026-03-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amitriptyline Hydrochloride generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	9d00b912-69be-4d9a-8c81-42cfc9bf6e09	2026-03-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amitriptyline Hydrochloride generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	451b8742-8b3c-4335-9075-c1d8313cd3d0	2026-02-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amitriptyline Hydrochloride generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	6f0c2fd1-0e0d-4f5f-80c4-266fcee09fa8	2026-02-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amitriptyline Hydrochloride generic name: AMITRIPTYLINE HYDROCHLORIDE

Application 085864

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

openFDA label cross-check#