Application 014684
- Type
- NDA
- Sponsor
- LILLY
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AVENTYL HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 10MG BASE | No | No |
| 002 | AVENTYL HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 25MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N014684-001 | AVENTYL HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | Approved before 1982 | ||
| N014684-002 | AVENTYL HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / 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.
| 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 | N014684-001 | AVENTYL HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N014684-002 | AVENTYL HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N014684-001 | AVENTYL HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N014684-002 | AVENTYL HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N014684-001 | AVENTYL HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N014684-002 | AVENTYL HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N014684-001 | AVENTYL HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N014684-002 | AVENTYL HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N014684-001 | AVENTYL HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N014684-002 | AVENTYL HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N014684-001 | AVENTYL HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N014684-002 | AVENTYL HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N014684-001 | AVENTYL HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N014684-002 | AVENTYL HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N014684-001 | AVENTYL HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N014684-002 | AVENTYL HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N014684-001 | AVENTYL HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N014684-002 | AVENTYL HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N014684-001 | AVENTYL HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N014684-002 | AVENTYL HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N014684-001 | AVENTYL HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N014684-002 | AVENTYL HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N014684-001 | AVENTYL HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N014684-002 | AVENTYL HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N014684-001 | AVENTYL HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N014684-002 | AVENTYL HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N014684-001 | AVENTYL HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N014684-002 | AVENTYL HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N014684-001 | AVENTYL HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N014684-002 | AVENTYL HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N014684-001 | AVENTYL HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N014684-002 | AVENTYL HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N014684-001 | AVENTYL HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N014684-002 | AVENTYL HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N014684-001 | AVENTYL HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N014684-002 | AVENTYL HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N014684-001 | AVENTYL HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N014684-002 | AVENTYL HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N014684-001 | AVENTYL HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N014684-002 | AVENTYL HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | Approved before 1982 | 74a2ff9319b5… |
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 |
|---|---|---|---|---|---|---|
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | REMEDYREPACK INC. | 4852a754-2fc1-4c10-a414-dc8a1dfd66a2 | 2026-09-03 | Boxed warning, Warnings, Adverse reactions | NORTRIPTYLINE HYDROCHLORIDE |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | REMEDYREPACK INC. | c7cce83f-9508-49de-a442-246ad18ddeda | 2026-08-27 | Boxed warning, Warnings, Adverse reactions | NORTRIPTYLINE HYDROCHLORIDE |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Bryant Ranch Prepack | cb4d1a69-60ae-4fdc-8af8-059959cf7265 | 2026-08-18 | Boxed warning, Warnings, Adverse reactions | NORTRIPTYLINE HYDROCHLORIDE |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | f684e9c8-eca7-4e27-872d-c0adea19de9a | 2026-08-04 | Boxed warning, Warnings, Adverse reactions | NORTRIPTYLINE HYDROCHLORIDE |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | NORTRIPTYLINE HYDROCHLORIDE |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Proficient Rx LP | 1e32f284-a5b2-4ebf-9d9e-0e9a40b46ade | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | NORTRIPTYLINE HYDROCHLORIDE |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 3c57301f-5128-295e-e063-6394a90ad99e | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | NORTRIPTYLINE HYDROCHLORIDE |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | REMEDYREPACK INC. | dd1f4d6f-14cc-44c0-b9d3-bb3d17b557fa | 2026-06-12 | Boxed warning, Warnings, Adverse reactions | NORTRIPTYLINE HYDROCHLORIDE |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | REMEDYREPACK INC. | 522d0cd8-d84d-4961-a525-4527fce44c3c | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | NORTRIPTYLINE HYDROCHLORIDE |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | REMEDYREPACK INC. | 27e96d6c-b311-45d2-b879-65c6a4efcfba | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | NORTRIPTYLINE HYDROCHLORIDE |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | ST. MARY'S MEDICAL PARK PHARMACY | 21770082-7a99-520d-e063-6394a90ab9cb | 2026-05-19 | Boxed warning, Warnings, Adverse reactions | NORTRIPTYLINE HYDROCHLORIDE |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | A-S Medication Solutions | a2cf7783-7019-49ea-ab55-796674d94546 | 2026-03-24 | Boxed warning, Warnings, Adverse reactions | NORTRIPTYLINE HYDROCHLORIDE |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Bryant Ranch Prepack | 8eef261f-5c78-a88f-37c4-46e6b0e0f0ee | 2026-03-10 | Boxed warning, Warnings, Adverse reactions | NORTRIPTYLINE HYDROCHLORIDE |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Coupler LLC | 4c21abdb-f3e9-9037-e063-6294a90af4b4 | 2026-03-03 | Boxed warning, Warnings, Adverse reactions | NORTRIPTYLINE HYDROCHLORIDE |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | PAI Holdings, LLC dba PAI Pharma | 3fcabf90-357a-4a06-b680-9572dc28bcfe | 2026-01-26 | Boxed warning, Warnings, Adverse reactions | NORTRIPTYLINE HYDROCHLORIDE |
| NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | Direct Rx | 017f7717-e160-4142-9a5a-1a2bd9776707 | 2026-01-13 | Boxed warning, Warnings, Adverse reactions | NORTRIPTYLINE HYDROCHLORIDE |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Advagen Pharma Ltd | bef9e24d-e730-4801-ab25-75e7d6bde225 | 2026-01-07 | Boxed warning, Warnings, Adverse reactions | NORTRIPTYLINE HYDROCHLORIDE |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Northwind Health Company, LLC | dae3314f-3128-787f-e053-2995a90aff19 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | NORTRIPTYLINE HYDROCHLORIDE |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Northwind Health Company, LLC | 09a54dbd-6bde-3083-e063-6394a90a5297 | 2025-12-26 | Boxed warning, Warnings, Adverse reactions | NORTRIPTYLINE HYDROCHLORIDE |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | American Health Packaging | d111c36d-98ed-4f0d-97ea-86fe9048deee | 2025-12-01 | Boxed warning, Warnings, Adverse reactions | NORTRIPTYLINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 44004 | ORIG | 2007-05-09 |