Application 210086
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 002 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | TABLET;ORAL | 25MG | No | No |
| 003 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | TABLET;ORAL | 50MG | 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 |
|---|---|---|---|---|---|---|---|
| A210086-001 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2017-10-06 | |
| A210086-002 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2017-10-06 | |
| A210086-003 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2017-10-06 | |
| A210086-004 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2017-10-06 | |
| A210086-005 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2017-10-06 | |
| A210086-006 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2017-10-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A210086-001 | AB |
| A210086-002 | AB |
| A210086-003 | AB |
| A210086-004 | AB |
| A210086-005 | AB |
| A210086-006 | 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 | A210086-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2017-10-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210086-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2017-10-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210086-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2017-10-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210086-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2017-10-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210086-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2017-10-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210086-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2017-10-06 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210086-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2017-10-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210086-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2017-10-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210086-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2017-10-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210086-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2017-10-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210086-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2017-10-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210086-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2017-10-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210086-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2017-10-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210086-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2017-10-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210086-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2017-10-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210086-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2017-10-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210086-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2017-10-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210086-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2017-10-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210086-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2017-10-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210086-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2017-10-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210086-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2017-10-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210086-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2017-10-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210086-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2017-10-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210086-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2017-10-06 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210086-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2017-10-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210086-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2017-10-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210086-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2017-10-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210086-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2017-10-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210086-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2017-10-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210086-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2017-10-06 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210086-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2017-10-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210086-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2017-10-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210086-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2017-10-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210086-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2017-10-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210086-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2017-10-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210086-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2017-10-06 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210086-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2017-10-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210086-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2017-10-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210086-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2017-10-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210086-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2017-10-06 | 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 | A210086-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210086-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210086-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210086-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210086-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210086-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210086-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210086-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210086-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210086-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210086-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210086-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A210086-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210086-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210086-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210086-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210086-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210086-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210086-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210086-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210086-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210086-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210086-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210086-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210086-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210086-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210086-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210086-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210086-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210086-006 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210086-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210086-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210086-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210086-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210086-005 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210086-006 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210086-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210086-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210086-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210086-004 | 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 | Coupler LLC | 5070fa18-ecc9-de14-e063-6394a90a372e | 2026-04-27 | Boxed warning, Warnings, Adverse reactions | 210086 ANDA210086 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | American Health Packaging | 98cc0bf3-ae5b-47cc-992f-9157fed7c3f4 | 2025-11-25 | Boxed warning, Adverse reactions | 210086 ANDA210086 60687-444 60687-433 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 43454445-b9cf-1378-e063-6294a90a1cc6 | 2025-11-10 | Boxed warning, Warnings, Adverse reactions | 210086 ANDA210086 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Zydus Lifesciences Limited | 4159b10e-f589-486c-969d-9b4544b098b5 | 2025-10-04 | 210086 ANDA210086 70771-1178 70771-1175 70771-1174 70771-1177 70771-1173 70771-1176 | |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Northstar Rx LLC. | 8ed28f42-e41a-45ca-a86f-849ebeb6ab80 | 2025-06-17 | Boxed warning, Warnings, Adverse reactions | 210086 ANDA210086 16714-262 16714-260 16714-258 16714-259 16714-261 16714-257 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Zydus Pharmaceuticals USA Inc. | 73669354-babc-4687-a4fe-ad0fc1f863ba | 2025-03-25 | Boxed warning, Warnings, Adverse reactions | 210086 ANDA210086 70710-1226 70710-1228 70710-1229 70710-1227 70710-1225 70710-1230 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | A-S Medication Solutions | b793f1f8-c1f9-46f0-8156-1a4957db3a1f | 2024-06-25 | Boxed warning, Warnings, Adverse reactions | 210086 ANDA210086 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | A-S Medication Solutions | 0067b698-ee1d-4524-b1cc-af1028d13736 | 2024-06-12 | Boxed warning, Warnings, Adverse reactions | 210086 ANDA210086 50090-4005 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | A-S Medication Solutions | 5e8c8c5f-4964-4642-ad4b-69a75b2c8a02 | 2023-12-18 | Boxed warning, Warnings, Adverse reactions | 210086 ANDA210086 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | A-S Medication Solutions | d22879c5-925a-42e0-9d48-55a422192983 | 2023-12-18 | Boxed warning, Warnings, Adverse reactions | 210086 ANDA210086 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16714-257 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Northstar Rx LLC. | ANDA | Current |
| 16714-257 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Northstar Rx LLC. | ANDA | Current |
| 16714-258 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Northstar Rx LLC. | ANDA | Current |
| 16714-258 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Northstar Rx LLC. | ANDA | Current |
| 16714-259 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Northstar Rx LLC. | ANDA | Current |
| 16714-259 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Northstar Rx LLC. | ANDA | Current |
| 16714-260 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Northstar Rx LLC. | ANDA | Current |
| 16714-260 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Northstar Rx LLC. | ANDA | Current |
| 16714-261 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Northstar Rx LLC. | ANDA | Current |
| 16714-261 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Northstar Rx LLC. | ANDA | Current |
| 16714-262 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Northstar Rx LLC. | ANDA | Current |
| 16714-262 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Northstar Rx LLC. | ANDA | Current |
| 50090-3784 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3784 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3784 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3985 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3985 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3986 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3986 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3986 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4005 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4005 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4005 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 60687-433 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-433 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-433 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-433 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-444 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-444 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-444 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-444 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | American Health Packaging | ANDA | Current |
| 70710-1225 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 70710-1225 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1225 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1225 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1226 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 70710-1226 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1226 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1226 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1227 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 70710-1227 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1227 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1227 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1228 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 70710-1228 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1228 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1228 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1229 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 70710-1229 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1229 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1229 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1230 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 70710-1230 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1230 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1230 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70771-1173 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 70771-1173 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1173 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 70771-1173 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 70771-1174 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 70771-1174 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1174 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 70771-1174 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 70771-1175 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 70771-1175 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1175 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 70771-1175 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 70771-1176 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 70771-1176 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1176 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 70771-1176 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 70771-1177 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 70771-1177 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1177 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 70771-1177 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 70771-1178 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 70771-1178 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1178 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 70771-1178 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Cadila Healthcare Limited | ANDA | Current |