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 |
|---|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A086009-001 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | Approved before 1982 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A086009-002 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | Approved before 1982 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A086009-003 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | Approved before 1982 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A086009-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | Approved before 1982 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A086009-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | Approved before 1982 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A086009-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | Approved before 1982 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A086009-001 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A086009-002 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A086009-003 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A086009-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A086009-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A086009-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A086009-001 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | Approved before 1982 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A086009-002 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | Approved before 1982 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A086009-003 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | Approved before 1982 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A086009-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | Approved before 1982 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A086009-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | Approved before 1982 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A086009-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A086009-001 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | Approved before 1982 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A086009-002 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | Approved before 1982 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A086009-003 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | Approved before 1982 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A086009-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | Approved before 1982 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A086009-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | Approved before 1982 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A086009-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | Approved before 1982 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A086009-001 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | Approved before 1982 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | A086009-002 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | Approved before 1982 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | A086009-003 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | Approved before 1982 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | A086009-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | Approved before 1982 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | A086009-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | Approved before 1982 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | A086009-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | Approved before 1982 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A086009-001 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | Approved before 1982 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | A086009-002 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | Approved before 1982 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | A086009-003 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | Approved before 1982 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | A086009-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | Approved before 1982 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | A086009-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | Approved before 1982 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | A086009-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | Approved before 1982 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A086009-001 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | Approved before 1982 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | A086009-002 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | Approved before 1982 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | A086009-003 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | Approved before 1982 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | A086009-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | Approved before 1982 | c0c555d07b60… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A086009-001 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A086009-002 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A086009-003 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A086009-004 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A086009-005 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A086009-006 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A086009-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A086009-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A086009-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A086009-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A086009-005 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A086009-006 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A086009-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A086009-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A086009-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A086009-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A086009-005 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A086009-006 | AB | 1 | caaa826d4ba7… |
| 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… |
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 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 |