Application 085968
- Type
- ANDA
- Sponsor
- SANDOZ
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 | 25MG | No | Yes |
| 003 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No |
| 004 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 005 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | TABLET;ORAL | 150MG | No | No |
| 006 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | TABLET;ORAL | 75MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A085968-001 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RLD, Approved before 1982 | |
| A085968-002 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | |
| A085968-003 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | RLD, Approved before 1982 | |
| A085968-004 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | RLD, Approved before 1982 | |
| A085968-005 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | RLD, Approved before 1982 | |
| A085968-006 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | RLD, Approved before 1982 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A085968-001 | AB |
| A085968-002 | AB |
| A085968-003 | AB |
| A085968-004 | AB |
| A085968-005 | AB |
| A085968-006 | 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 | A085968-001 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A085968-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A085968-003 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A085968-004 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A085968-005 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A085968-006 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085968-001 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085968-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085968-003 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085968-004 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085968-005 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085968-006 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A085968-001 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A085968-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A085968-003 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A085968-004 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A085968-005 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A085968-006 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085968-001 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085968-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085968-003 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085968-004 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085968-005 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085968-006 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085968-001 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085968-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085968-003 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085968-004 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085968-005 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085968-006 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085968-001 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085968-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085968-003 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085968-004 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085968-005 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085968-006 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A085968-001 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A085968-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A085968-003 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A085968-004 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A085968-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A085968-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A085968-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A085968-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A085968-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A085968-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085968-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085968-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085968-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085968-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085968-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085968-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A085968-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A085968-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A085968-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A085968-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A085968-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A085968-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085968-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085968-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085968-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085968-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085968-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085968-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085968-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085968-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085968-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085968-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085968-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085968-006 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085968-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085968-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085968-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085968-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085968-005 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085968-006 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A085968-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A085968-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A085968-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A085968-004 | AB | 1 | 2680178bc6a6… |
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 | Northwind Health Company, LLC | 471f3a17-baaa-cc35-e063-6294a90aed96 | 2025-12-29 | Boxed warning, Warnings, Adverse reactions | 085968 ANDA085968 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 1523a2b4-f9d6-4d3c-a370-df579ed36911 | 2025-07-15 | Boxed warning, Warnings, Adverse reactions | 085968 ANDA085968 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | d7bfeb47-2482-4217-b522-df4444499133 | 2025-07-15 | Boxed warning, Warnings, Adverse reactions | 085968 ANDA085968 43063-836 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Sandoz Inc | 705a2bae-031d-4218-82fe-4346542c0baa | 2025-05-30 | Boxed warning, Warnings, Adverse reactions | 085968 ANDA085968 0781-1489 0781-1490 0781-1487 0781-1486 0781-1488 0781-1491 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0615-0830 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0781-1486 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-1486 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-1486 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-1487 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-1487 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-1487 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-1488 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-1488 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-1488 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-1488 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-1488 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-1488 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-1488 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-1489 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-1489 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-1489 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-1490 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-1490 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-1490 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-1491 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-1491 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-1491 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Sandoz Inc | ANDA | Current |
| 0904-0201 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-0201 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-0202 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-0202 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-0202 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-0202 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-0202 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-0202 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 10544-110 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Blenheim Pharmacal, Inc. | ANDA | Current |
| 16714-446 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Northstar RxLLC | ANDA | Current |
| 16714-447 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Northstar RxLLC | ANDA | Current |
| 16714-448 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Northstar RxLLC | ANDA | Current |
| 16714-448 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Northstar RxLLC | ANDA | Current |
| 16714-448 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Northstar RxLLC | ANDA | Current |
| 16714-448 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Northstar RxLLC | ANDA | Current |
| 16714-449 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Northstar RxLLC | ANDA | Current |
| 16714-450 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Northstar RxLLC | ANDA | Current |
| 16714-451 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Northstar RxLLC | ANDA | Current |
| 21695-252 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Rebel Distributors Corp. | ANDA | Current |
| 35356-742 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | ANDA | Current |
| 43063-836 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-836 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-836 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-836 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-836 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-836 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43353-164 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-164 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 50090-5754 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 52959-514 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | H.J. Harkins Company, Inc. | ANDA | Current |
| 55154-7898 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Cardinal Health | ANDA | Current |
| 63629-3597 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 64725-1488 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | TYA Pharmaceuticals | ANDA | Current |
| 67046-012 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Contract Pharmacy Services-PA | ANDA | Current |
| 68071-4238 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4238 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4238 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4238 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-9015 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 69158-002 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | GLENVIEW PHARMA INC. | ANDA | Current |