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 | A-S Medication Solutions | 686d15d0-6434-42ec-8c78-f45d617d294c | 2025-12-01 | Boxed warning, Warnings, Adverse reactions | NORTRIPTYLINE HYDROCHLORIDE |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Bryant Ranch Prepack | 962f3f54-0556-4509-a231-ca62cb01bec8 | 2025-11-17 | Boxed warning, Warnings, Adverse reactions | NORTRIPTYLINE HYDROCHLORIDE |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Bryant Ranch Prepack | 43a81887-42b8-43b5-b58a-3f3df2e9949b | 2025-11-07 | Boxed warning, Warnings, Adverse reactions | NORTRIPTYLINE HYDROCHLORIDE |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | ba4edb34-82ac-4c98-8abd-fd6176838c78 | 2025-10-16 | Boxed warning, Warnings, Adverse reactions | NORTRIPTYLINE HYDROCHLORIDE |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | dbb3cc4d-c36d-495d-b9fc-e5513b2f6b93 | 2025-10-14 | Boxed warning, Warnings, Adverse reactions | NORTRIPTYLINE HYDROCHLORIDE |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Bryant Ranch Prepack | 6b055ebf-ed9e-44c5-bc03-6b6480d14377 | 2025-10-13 | Boxed warning, Warnings, Adverse reactions | NORTRIPTYLINE HYDROCHLORIDE |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Teva Pharmaceuticals USA, Inc. | b58d473a-b19f-4d2a-b1ae-dd398d7a29e1 | 2025-09-30 | Boxed warning, Warnings, Adverse reactions | NORTRIPTYLINE HYDROCHLORIDE |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 60763e7a-d22c-47d5-a260-f64bd4a4f654 | 2025-07-10 | Boxed warning, Warnings, Adverse reactions | NORTRIPTYLINE HYDROCHLORIDE |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 36b00c00-5fbd-c14b-e063-6294a90a49b7 | 2025-06-03 | Boxed warning, Warnings, Adverse reactions | NORTRIPTYLINE HYDROCHLORIDE |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Coupler LLC | 2fffe23d-37f8-34fe-e063-6294a90a7b6c | 2025-03-10 | Boxed warning, Warnings, Adverse reactions | NORTRIPTYLINE HYDROCHLORIDE |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Coupler LLC | 2ccb3fd0-53c9-6015-e063-6294a90a3fd6 | 2025-01-28 | Boxed warning, Warnings, Adverse reactions | NORTRIPTYLINE HYDROCHLORIDE |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Asclemed USA, Inc. | b02eb04a-83ee-45b0-b755-187fde2698c3 | 2025-01-27 | Boxed warning, Warnings, Adverse reactions | NORTRIPTYLINE HYDROCHLORIDE |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Coupler LLC | 2c92511f-0127-c74e-e063-6394a90a1214 | 2025-01-25 | Boxed warning, Warnings, Adverse reactions | NORTRIPTYLINE HYDROCHLORIDE |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Zydus Lifesciences Limited | f22dce73-b895-4fe2-8cf7-816dca93c246 | 2024-12-11 | Boxed warning, Warnings, Adverse reactions | NORTRIPTYLINE HYDROCHLORIDE |
| PAMELOR | NORTRIPTYLINE HYDROCHLORIDE | SpecGx LLC | e17dc299-f52d-414d-ab6e-e809bd6f8acb | 2024-12-04 | Boxed warning, Warnings, Adverse reactions | NORTRIPTYLINE HYDROCHLORIDE |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Proficient Rx LP | e047f990-c374-4f8f-8583-c615f92545e2 | 2024-10-01 | Boxed warning, Warnings, Adverse reactions | NORTRIPTYLINE HYDROCHLORIDE |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Proficient Rx LP | 2f9fc7a0-163a-4a05-84a7-7999a41ecb1f | 2024-10-01 | Boxed warning, Warnings, Adverse reactions | NORTRIPTYLINE HYDROCHLORIDE |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Proficient Rx LP | b387ba49-fd3f-4488-86e8-9b81e85ab232 | 2024-10-01 | Boxed warning, Warnings, Adverse reactions | NORTRIPTYLINE HYDROCHLORIDE |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Proficient Rx LP | 661ec73c-d893-446a-83c3-218b06889962 | 2024-09-01 | Boxed warning, Warnings, Adverse reactions | NORTRIPTYLINE HYDROCHLORIDE |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Bryant Ranch Prepack | d72e5d1d-58f2-4d34-900a-54e5feb2f3eb | 2024-08-22 | 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 |