Application 012704
- Type
- NDA
- Sponsor
- ASTRAZENECA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ELAVIL | AMITRIPTYLINE HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N012704-001 | ELAVIL | AMITRIPTYLINE HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N012704-001 | ELAVIL | 10MG/ML | INJECTABLE / INJECTION | Approved before 1982 | f41ea6bd6efb… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | A-S Medication Solutions | 9110367c-4104-4836-8af3-649f86b0b3ea | 2025-07-09 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Major Pharmaceuticals | 29ec1221-04d8-4b21-822e-2779fcaae62c | 2025-06-27 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | A-S Medication Solutions | 85574987-8d31-4bd0-b829-bb154ef212f5 | 2025-06-24 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Northstar Rx LLC. | 8ed28f42-e41a-45ca-a86f-849ebeb6ab80 | 2025-06-17 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Unichem Pharmaceuticals (USA), Inc. | 9c6e0e05-b579-4fae-b768-e1a664c39bb8 | 2025-06-10 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Sandoz Inc | 705a2bae-031d-4218-82fe-4346542c0baa | 2025-05-30 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | ST. MARY'S MEDICAL PARK PHARMACY | 35a6e911-507a-ef0d-e063-6294a90a07e1 | 2025-05-21 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | ST. MARY'S MEDICAL PARK PHARMACY | 35a7ce7d-4a29-e3f0-e063-6294a90ad66f | 2025-05-21 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Bryant Ranch Prepack | 2bda8478-f5ab-440a-a8a3-61ebc5721369 | 2025-05-16 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Bryant Ranch Prepack | 86bad1a5-48c3-4a8a-970f-8fdbda078b4e | 2025-05-15 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Rising Pharma Holdings, Inc. | a219a68e-7ce5-4e9d-a0de-ec76960040f6 | 2025-04-03 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Zydus Pharmaceuticals USA Inc. | 73669354-babc-4687-a4fe-ad0fc1f863ba | 2025-03-25 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | A-S Medication Solutions | bbbd535d-0bce-469e-917f-70a6ebd2f007 | 2025-02-24 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | A-S Medication Solutions | 69c7a0bd-93d0-40fe-a6d3-f41986b802b4 | 2025-02-24 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | AvPAK | f5c5f3b6-e92b-1120-e053-2995a90ae8fa | 2025-01-09 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | AvPAK | fd771b4b-c7ae-8e69-e053-6294a90a2120 | 2025-01-09 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 082b620f-8085-d205-e063-6294a90ac6de | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | f98d25a7-6b47-38a9-e053-6394a90a541d | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | f78102eb-cbeb-801a-e053-6294a90ab880 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 19b0c015-c07f-63b7-e063-6394a90a6060 | 2024-11-18 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.