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 | Coupler LLC | 50375dab-97fe-8c84-e063-6394a90a60b2 | 2026-04-24 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Coupler LLC | 500f239c-0460-a22b-e063-6294a90a1ba6 | 2026-04-22 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Bryant Ranch Prepack | 9f9d6495-47ff-4dcf-9643-ebd5cd7499cb | 2026-04-10 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Lifestar Pharma LLC | 67e31675-1da2-4acf-84ac-77522b02f0b9 | 2026-04-08 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Aurobindo Pharma Limited | 8085a37f-3c76-4f74-aab3-9a929a7eb1c2 | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | A-S Medication Solutions | 53f4f83c-4bfd-43d6-9bb8-82c21ed2864f | 2026-03-23 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | A-S Medication Solutions | 9d00b912-69be-4d9a-8c81-42cfc9bf6e09 | 2026-03-18 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 451b8742-8b3c-4335-9075-c1d8313cd3d0 | 2026-02-26 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 6f0c2fd1-0e0d-4f5f-80c4-266fcee09fa8 | 2026-02-23 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 8b10ac1a-cf66-4efa-9abc-498b2f8a1613 | 2026-02-23 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | cf03c1a1-cbd5-47dc-a5e8-70ec32b71cb1 | 2026-02-23 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | b2f822aa-23c0-4833-afc8-f5a611b9ad5a | 2026-02-23 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 5dd07852-43a5-415c-863e-1202f82b5654 | 2026-02-20 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ba6a83c4-2993-40ca-bb8f-2d6c5c3e3e26 | 2026-02-20 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | A-S Medication Solutions | 5fe84552-9650-42e4-9870-add97b46dfe1 | 2026-02-13 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Bryant Ranch Prepack | 3893689b-f794-4dfd-9bd4-3fa53069e35f | 2026-02-04 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 147d2f8f-842d-4f09-86b0-a66edce27778 | 2026-01-23 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 54485767-d7c5-4927-ae52-08537a7a91e8 | 2026-01-20 | Boxed warning, Warnings, Adverse reactions | 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 | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Northwind Health Company, LLC | 43450e62-d8c1-b39e-e063-6294a90a42ee | 2026-01-02 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.