Application 086009
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | TABLET;ORAL | 50MG | No | No |
| 002 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 003 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | TABLET;ORAL | 25MG | No | No |
| 004 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | TABLET;ORAL | 75MG | No | No |
| 005 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No |
| 006 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | TABLET;ORAL | 150MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A086009-001 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | Approved before 1982 | |
| A086009-002 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | Approved before 1982 | |
| A086009-003 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | Approved before 1982 | |
| A086009-004 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | Approved before 1982 | |
| A086009-005 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | Approved before 1982 | |
| A086009-006 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | Approved before 1982 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A086009-001 | AB |
| A086009-002 | AB |
| A086009-003 | AB |
| A086009-004 | AB |
| A086009-005 | AB |
| A086009-006 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A086009-001 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A086009-002 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A086009-003 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A086009-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A086009-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A086009-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A086009-001 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A086009-002 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A086009-003 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A086009-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A086009-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A086009-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A086009-001 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A086009-002 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A086009-003 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A086009-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A086009-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A086009-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A086009-001 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A086009-002 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A086009-003 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A086009-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A086009-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A086009-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A086009-001 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A086009-002 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A086009-003 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A086009-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A086009-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A086009-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A086009-001 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A086009-002 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A086009-003 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A086009-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A086009-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A086009-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A086009-001 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A086009-002 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A086009-003 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A086009-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A086009-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A086009-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A086009-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A086009-004 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A086009-005 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A086009-006 | AB | 1 | 74a2ff9319b5… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A086009-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A086009-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A086009-003 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A086009-004 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A086009-005 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A086009-006 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A086009-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A086009-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A086009-003 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A086009-004 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A086009-005 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A086009-006 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A086009-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A086009-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A086009-003 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A086009-004 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A086009-005 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A086009-006 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A086009-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A086009-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A086009-003 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A086009-004 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A086009-005 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A086009-006 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A086009-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A086009-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A086009-003 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A086009-004 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A086009-005 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A086009-006 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A086009-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A086009-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A086009-003 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A086009-004 | AB | 1 | b00525d2431f… |
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 | Aurobindo Pharma Limited | 8085a37f-3c76-4f74-aab3-9a929a7eb1c2 | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | 086009 ANDA086009 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-2610 | Amitriptyline Hydrochloride | amitriptyline hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2610 | Amitriptyline Hydrochloride | amitriptyline hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2625 | Amitriptyline Hydrochloride | amitriptyline hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2625 | Amitriptyline Hydrochloride | amitriptyline hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2650 | Amitriptyline Hydrochloride | amitriptyline hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2650 | Amitriptyline Hydrochloride | amitriptyline hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2675 | Amitriptyline Hydrochloride | amitriptyline hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2675 | Amitriptyline Hydrochloride | amitriptyline hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2685 | Amitriptyline Hydrochloride | amitriptyline hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2685 | Amitriptyline Hydrochloride | amitriptyline hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2695 | Amitriptyline Hydrochloride | amitriptyline hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2695 | Amitriptyline Hydrochloride | amitriptyline hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 50090-2972 | Amitriptyline Hydrochloride | amitriptyline hydrochloride | A-S Medication Solutions | ANDA | Current |
| 51079-107 | Amitriptyline Hydrochloride | amitriptyline hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-107 | Amitriptyline Hydrochloride | amitriptyline hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-107 | Amitriptyline Hydrochloride | amitriptyline hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-107 | Amitriptyline Hydrochloride | amitriptyline hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-131 | Amitriptyline Hydrochloride | amitriptyline hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-131 | Amitriptyline Hydrochloride | amitriptyline hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-131 | Amitriptyline Hydrochloride | amitriptyline hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-131 | Amitriptyline Hydrochloride | amitriptyline hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-133 | Amitriptyline Hydrochloride | amitriptyline hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-133 | Amitriptyline Hydrochloride | amitriptyline hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-133 | Amitriptyline Hydrochloride | amitriptyline hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-133 | Amitriptyline Hydrochloride | amitriptyline hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-147 | Amitriptyline Hydrochloride | amitriptyline hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-147 | Amitriptyline Hydrochloride | amitriptyline hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-147 | Amitriptyline Hydrochloride | amitriptyline hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-563 | Amitriptyline Hydrochloride | amitriptyline hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-563 | Amitriptyline Hydrochloride | amitriptyline hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-563 | Amitriptyline Hydrochloride | amitriptyline hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 55154-5665 | Amitriptyline Hydrochloride | amitriptyline hydrochloride | Cardinal Health | ANDA | Current |
| 55154-5665 | Amitriptyline Hydrochloride | amitriptyline hydrochloride | Cardinal Health | ANDA | Current |
| 61919-013 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Direct Rx | ANDA | Current |
| 61919-013 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Direct Rx | ANDA | Current |
| 63629-6311 | Amitriptyline Hydrochloride | amitriptyline hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-6311 | Amitriptyline Hydrochloride | amitriptyline hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 67296-1245 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1245 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |