Application 214548
- Type
- ANDA
- Sponsor
- UNICHEM
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 |
|---|---|---|---|---|---|---|---|
| A214548-001 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2021-05-19 | |
| A214548-002 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2021-05-19 | |
| A214548-003 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2021-05-19 | |
| A214548-004 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2021-05-19 | |
| A214548-005 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2021-05-19 | |
| A214548-006 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2021-05-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A214548-001 | AB |
| A214548-002 | AB |
| A214548-003 | AB |
| A214548-004 | AB |
| A214548-005 | AB |
| A214548-006 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A214548-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2021-05-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A214548-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2021-05-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A214548-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2021-05-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A214548-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2021-05-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A214548-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2021-05-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A214548-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2021-05-19 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A214548-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2021-05-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A214548-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2021-05-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A214548-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2021-05-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A214548-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2021-05-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A214548-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2021-05-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A214548-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2021-05-19 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214548-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2021-05-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214548-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2021-05-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214548-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2021-05-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214548-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2021-05-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214548-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2021-05-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214548-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2021-05-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214548-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2021-05-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214548-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2021-05-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214548-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2021-05-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214548-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2021-05-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214548-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2021-05-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214548-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2021-05-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214548-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2021-05-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214548-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2021-05-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214548-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2021-05-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214548-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2021-05-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214548-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2021-05-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214548-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2021-05-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214548-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2021-05-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214548-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2021-05-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214548-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2021-05-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214548-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2021-05-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214548-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2021-05-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214548-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2021-05-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214548-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2021-05-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214548-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2021-05-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214548-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2021-05-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214548-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2021-05-19 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A214548-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A214548-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A214548-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A214548-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A214548-005 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A214548-006 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A214548-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A214548-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A214548-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A214548-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A214548-005 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A214548-006 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A214548-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A214548-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A214548-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A214548-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A214548-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A214548-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214548-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214548-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214548-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214548-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214548-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214548-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A214548-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A214548-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A214548-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A214548-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A214548-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A214548-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214548-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214548-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214548-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214548-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214548-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214548-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214548-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214548-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214548-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214548-004 | AB | 1 | b8a1b40f171c… |
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 | Bryant Ranch Prepack | 2bda8478-f5ab-440a-a8a3-61ebc5721369 | 2025-05-16 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Bryant Ranch Prepack | 86bad1a5-48c3-4a8a-970f-8fdbda078b4e | 2025-05-15 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 |
| Amitriptyline HCL | AMITRIPTYLINE HCL | Direct_Rx | 3504be24-1e75-5e68-e063-6294a90a270a | 2025-05-13 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | A-S Medication Solutions | bbbd535d-0bce-469e-917f-70a6ebd2f007 | 2025-02-24 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | A-S Medication Solutions | 69c7a0bd-93d0-40fe-a6d3-f41986b802b4 | 2025-02-24 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 50090-6313 |
| AMITRIPTYLINE HCL | AMITRIPTYLINE HCL | Direct_Rx | f420498a-bfcc-4549-e053-2995a90a7b09 | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 |
| Amitriptyline HCL | AMITRIPTYLINE HCL | Direct_Rx | f6dc463b-3601-48c0-e053-6294a90a2d77 | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | AvPAK | f5c5f3b6-e92b-1120-e053-2995a90ae8fa | 2025-01-09 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | AvPAK | fd771b4b-c7ae-8e69-e053-6294a90a2120 | 2025-01-09 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 082b620f-8085-d205-e063-6294a90ac6de | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | f98d25a7-6b47-38a9-e053-6394a90a541d | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | f78102eb-cbeb-801a-e053-6294a90ab880 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Bryant Ranch Prepack | 8c9f605f-ac13-442f-af4d-ea11102474de | 2024-08-28 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Bryant Ranch Prepack | ac1a7640-58d7-494d-94c8-27911470bf59 | 2024-08-27 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Bryant Ranch Prepack | 6a176cd7-7c13-440e-b6bb-dc2fab3f2a12 | 2024-08-16 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 18ff2901-08fd-37f0-e063-6394a90a1ad2 | 2024-05-21 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Proficient Rx LP | ce665435-b2f1-4fcd-ae20-4f372f376095 | 2024-05-01 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Asclemed USA, Inc. | 776d2c2c-d897-4da1-a99a-b4324e1f864f | 2024-03-02 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Proficient Rx LP | 61133866-b01c-4278-93fb-4564c1b56e54 | 2024-03-01 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | A-S Medication Solutions | 00d11130-c9ae-4258-9746-9763bc5deb84 | 2023-12-22 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 50090-6179 |
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 |
|---|---|---|---|---|---|
| 29300-419 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-419 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-420 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-420 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-421 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-421 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-422 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-422 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-423 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-423 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-424 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-424 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 50090-6179 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-6313 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-6315 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 60760-556 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | ST. MARY'S MEDICAL PARK PHARMACY | ANDA | Current |
| 68071-2796 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2843 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-8218 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |