Application 086148

Type: ANDA
Sponsor: ROXANE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	TABLET;ORAL	150MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A086148-001	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	150MG	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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086148-001	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`e64feba35796…`

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 3 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	REMEDYREPACK INC.	56379133-cd11-4dff-b511-7cdfc9a360ca	2025-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amitriptyline Hydrochloride generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	American Health Packaging	98cc0bf3-ae5b-47cc-992f-9157fed7c3f4	2025-11-25	Boxed warning, Adverse reactions	Name fallback brand name: Amitriptyline Hydrochloride generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	15c2afe3-3309-4abc-87d1-f3eab8d89b20	2025-11-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amitriptyline Hydrochloride generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	43454445-b9cf-1378-e063-6294a90a1cc6	2025-11-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amitriptyline Hydrochloride generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	AiPing Pharmaceutical, Inc.	33807ee6-8443-4613-8bbe-d66f6010fc60	2025-11-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amitriptyline Hydrochloride generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	4132f91e-6f24-476a-9028-bab86ad0598e	2025-10-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amitriptyline Hydrochloride generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Zydus Lifesciences Limited	4159b10e-f589-486c-969d-9b4544b098b5	2025-10-04		Name fallback brand name: Amitriptyline Hydrochloride generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	db4d83b8-3ce7-433e-b32a-a8dc2f44b909	2025-10-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amitriptyline Hydrochloride generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	63cd768c-4ed1-47af-901a-3835919ca4d9	2025-10-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amitriptyline Hydrochloride generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	c072c1b3-ed8a-4f1e-ba6c-580a2b2c8f58	2025-10-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amitriptyline Hydrochloride generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	61b29703-cfc2-45c7-ae24-7bf3b77e8587	2025-10-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amitriptyline Hydrochloride generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	bb02d7b8-8f1a-4cc4-b763-223e6894f02c	2025-09-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amitriptyline Hydrochloride generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Westminster Pharmaceuticals, LLC	d46ff585-7082-4a7c-a88f-2acf3be0f1d5	2025-08-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amitriptyline Hydrochloride generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	04e1c5f8-de7e-8ce7-e063-6394a90acc57	2025-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amitriptyline Hydrochloride generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	1523a2b4-f9d6-4d3c-a370-df579ed36911	2025-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amitriptyline Hydrochloride generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	d7bfeb47-2482-4217-b522-df4444499133	2025-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amitriptyline Hydrochloride generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	9110367c-4104-4836-8af3-649f86b0b3ea	2025-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amitriptyline Hydrochloride generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Major Pharmaceuticals	29ec1221-04d8-4b21-822e-2779fcaae62c	2025-06-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amitriptyline Hydrochloride generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	85574987-8d31-4bd0-b829-bb154ef212f5	2025-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amitriptyline Hydrochloride generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	e0aa02a9-3e2d-44c5-a6b9-843c80102249	2025-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amitriptyline Hydrochloride generic name: AMITRIPTYLINE HYDROCHLORIDE

Application 086148

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

openFDA label cross-check#