Application 083639

Type: ANDA
Sponsor: ROCHE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ENDEP	AMITRIPTYLINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
002	ENDEP	AMITRIPTYLINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	No
003	ENDEP	AMITRIPTYLINE HYDROCHLORIDE	TABLET;ORAL	50MG	No	No
004	ENDEP	AMITRIPTYLINE HYDROCHLORIDE	TABLET;ORAL	75MG	No	No
005	ENDEP	AMITRIPTYLINE HYDROCHLORIDE	TABLET;ORAL	100MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
A083639-001	ENDEP	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982
A083639-002	ENDEP	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982
A083639-003	ENDEP	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982
A083639-004	ENDEP	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	Approved before 1982
A083639-005	ENDEP	AMITRIPTYLINE HYDROCHLORIDE	100MG	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 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	A083639-001	ENDEP	10MG	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A083639-002	ENDEP	25MG	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A083639-003	ENDEP	50MG	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A083639-004	ENDEP	75MG	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A083639-005	ENDEP	100MG	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A083639-001	ENDEP	10MG	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A083639-002	ENDEP	25MG	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A083639-003	ENDEP	50MG	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A083639-004	ENDEP	75MG	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A083639-005	ENDEP	100MG	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A083639-001	ENDEP	10MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A083639-002	ENDEP	25MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A083639-003	ENDEP	50MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A083639-004	ENDEP	75MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A083639-005	ENDEP	100MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083639-001	ENDEP	10MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083639-002	ENDEP	25MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083639-003	ENDEP	50MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083639-004	ENDEP	75MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083639-005	ENDEP	100MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083639-001	ENDEP	10MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A083639-002	ENDEP	25MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A083639-003	ENDEP	50MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A083639-004	ENDEP	75MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A083639-005	ENDEP	100MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083639-001	ENDEP	10MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083639-002	ENDEP	25MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083639-003	ENDEP	50MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083639-004	ENDEP	75MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083639-005	ENDEP	100MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083639-001	ENDEP	10MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083639-002	ENDEP	25MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083639-003	ENDEP	50MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083639-004	ENDEP	75MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083639-005	ENDEP	100MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083639-001	ENDEP	10MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083639-002	ENDEP	25MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083639-003	ENDEP	50MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083639-004	ENDEP	75MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083639-005	ENDEP	100MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`

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 · 112 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	e3afe026-7072-0a7d-e053-2995a90a52d4	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Northwind Health Company, LLC	f67d6f73-88d7-2031-e053-2995a90a3b09	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Northwind Health Company, LLC	f8236cd1-1b60-4a66-e053-6294a90afeb0	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Northwind Health Company, LLC	f7e4ac7b-17bc-dae8-e053-6394a90a9cb6	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Northwind Health Company, LLC	471f3a17-baaa-cc35-e063-6294a90aed96	2025-12-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	085baad2-d1c7-499e-b553-7477befd04d0	2025-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	ace6748d-735c-4e6e-b327-a20101fd23d4	2025-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Coupler LLC	4616c2be-03a5-4279-e063-6294a90ac052	2025-12-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Advagen Pharma Ltd	651bd090-a420-4dd8-89b0-4cb766c144c2	2025-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback 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 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 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 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 generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Zydus Lifesciences Limited	4159b10e-f589-486c-969d-9b4544b098b5	2025-10-04		Name fallback 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 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 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 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 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 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 generic name: AMITRIPTYLINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.