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 6 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	A-S Medication Solutions	00d11130-c9ae-4258-9746-9763bc5deb84	2023-12-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	5e8c8c5f-4964-4642-ad4b-69a75b2c8a02	2023-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	d22879c5-925a-42e0-9d48-55a422192983	2023-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Proficient Rx LP	6dc9d113-1156-43ec-a7eb-253c2ff6bcfa	2023-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	25832051-837b-4682-8548-5ab9a1b7cdac	2023-11-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	4e0f3b15-3621-48a1-9f2b-b0a373920360	2023-09-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Proficient Rx LP	e42225f5-44bd-451e-98a1-aa3877457733	2023-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	1a622039-0a79-407c-8f15-2ea0c5844136	2023-04-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	8746c047-51b9-4040-aeec-cd1f5b6eb3d4	2023-03-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AMITRIPTYLINE HYDROCHLORIDE
AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	9440dd10-2f0d-42a7-a037-3ab8729708f6	2023-01-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Centaur Pharmaceuticals Private Limited	3d113e43-c694-427f-8b77-66be36a82374	2022-09-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AMITRIPTYLINE HYDROCHLORIDE
AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	Proficient Rx LP	df5aee40-ffa9-4cf3-ab5f-30253f43092b	2022-05-02	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.