Application 012703

Type: NDA
Sponsor: ASTRAZENECA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ELAVIL	AMITRIPTYLINE HYDROCHLORIDE	TABLET;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	ELAVIL	AMITRIPTYLINE HYDROCHLORIDE	TABLET;ORAL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	ELAVIL	AMITRIPTYLINE HYDROCHLORIDE	TABLET;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
005	ELAVIL	AMITRIPTYLINE HYDROCHLORIDE	TABLET;ORAL	75MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
006	ELAVIL	AMITRIPTYLINE HYDROCHLORIDE	TABLET;ORAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
007	ELAVIL	AMITRIPTYLINE HYDROCHLORIDE	TABLET;ORAL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
N012703-001	ELAVIL	AMITRIPTYLINE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N012703-003	ELAVIL	AMITRIPTYLINE HYDROCHLORIDE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N012703-004	ELAVIL	AMITRIPTYLINE HYDROCHLORIDE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N012703-005	ELAVIL	AMITRIPTYLINE HYDROCHLORIDE	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N012703-006	ELAVIL	AMITRIPTYLINE HYDROCHLORIDE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N012703-007	ELAVIL	AMITRIPTYLINE HYDROCHLORIDE	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, 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 7 · 258 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	N012703-001	ELAVIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N012703-003	ELAVIL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N012703-004	ELAVIL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N012703-005	ELAVIL	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N012703-006	ELAVIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N012703-007	ELAVIL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N012703-001	ELAVIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N012703-003	ELAVIL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N012703-004	ELAVIL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N012703-005	ELAVIL	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N012703-006	ELAVIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N012703-007	ELAVIL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N012703-001	ELAVIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012703-003	ELAVIL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012703-004	ELAVIL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012703-005	ELAVIL	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012703-006	ELAVIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012703-007	ELAVIL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012703-001	ELAVIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012703-003	ELAVIL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012703-004	ELAVIL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012703-005	ELAVIL	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012703-006	ELAVIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012703-007	ELAVIL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N012703-001	ELAVIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012703-003	ELAVIL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012703-004	ELAVIL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012703-005	ELAVIL	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012703-006	ELAVIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012703-007	ELAVIL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012703-001	ELAVIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012703-003	ELAVIL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012703-004	ELAVIL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012703-005	ELAVIL	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012703-006	ELAVIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012703-007	ELAVIL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012703-001	ELAVIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012703-003	ELAVIL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012703-004	ELAVIL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012703-005	ELAVIL	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`

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 2 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	Coupler LLC	50375dab-97fe-8c84-e063-6394a90a60b2	2026-04-24	Boxed warning, Warnings, Adverse reactions	Name fallback 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 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 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 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 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 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 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 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 generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	8b10ac1a-cf66-4efa-9abc-498b2f8a1613	2026-02-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	cf03c1a1-cbd5-47dc-a5e8-70ec32b71cb1	2026-02-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	b2f822aa-23c0-4833-afc8-f5a611b9ad5a	2026-02-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	5dd07852-43a5-415c-863e-1202f82b5654	2026-02-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	ba6a83c4-2993-40ca-bb8f-2d6c5c3e3e26	2026-02-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	5fe84552-9650-42e4-9870-add97b46dfe1	2026-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	3893689b-f794-4dfd-9bd4-3fa53069e35f	2026-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	147d2f8f-842d-4f09-86b0-a66edce27778	2026-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	54485767-d7c5-4927-ae52-08537a7a91e8	2026-01-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	ST. MARY'S MEDICAL PARK PHARMACY	485b87c3-2a51-133b-e063-6294a90a95c3	2026-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Northwind Health Company, LLC	43450e62-d8c1-b39e-e063-6294a90a42ee	2026-01-02	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.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44001	ORIG	2007-05-09
12031	SUPPL	2003-08-06
339	SUPPL	2001-03-27