Application 202446
- Type
- ANDA
- Sponsor
- ACCORD HLTHCARE
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 |
|---|---|---|---|---|---|---|---|
| A202446-001 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-06-04 | |
| A202446-002 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-06-04 | |
| A202446-003 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-06-04 | |
| A202446-004 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2014-06-04 | |
| A202446-005 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2014-06-04 | |
| A202446-006 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2014-06-04 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202446-001 | AB |
| A202446-002 | AB |
| A202446-003 | AB |
| A202446-004 | AB |
| A202446-005 | AB |
| A202446-006 | 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 | A202446-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-06-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A202446-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-06-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A202446-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-06-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A202446-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2014-06-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A202446-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2014-06-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A202446-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2014-06-04 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A202446-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-06-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202446-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-06-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202446-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-06-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202446-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2014-06-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202446-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2014-06-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202446-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2014-06-04 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202446-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-06-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202446-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-06-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202446-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-06-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202446-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2014-06-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202446-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2014-06-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202446-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2014-06-04 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202446-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-06-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202446-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-06-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202446-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-06-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202446-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2014-06-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202446-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2014-06-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202446-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2014-06-04 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202446-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-06-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202446-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-06-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202446-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-06-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202446-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2014-06-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202446-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2014-06-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202446-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2014-06-04 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202446-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-06-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202446-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-06-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202446-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-06-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202446-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2014-06-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202446-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2014-06-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202446-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2014-06-04 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202446-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-06-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202446-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-06-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202446-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-06-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202446-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2014-06-04 | 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 | A202446-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A202446-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A202446-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A202446-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A202446-005 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A202446-006 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A202446-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202446-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202446-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202446-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202446-005 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202446-006 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A202446-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202446-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202446-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202446-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202446-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202446-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202446-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202446-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202446-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202446-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202446-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202446-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202446-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202446-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202446-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202446-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202446-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202446-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202446-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202446-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202446-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202446-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202446-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202446-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202446-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202446-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202446-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202446-004 | 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 | Northwind Health Company, LLC | e3afe026-7072-0a7d-e053-2995a90a52d4 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 202446 ANDA202446 |
| Amitriptyline HCL | AMITRIPTYLINE HCL | Advanced Rx Pharmacy of Tennessee, LLC | ca66c2fc-6724-f4cd-e053-2995a90a42cf | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 202446 ANDA202446 |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Bryant Ranch Prepack | 76d3f4fd-4603-4cfc-94ab-2e62c0bdae75 | 2024-08-19 | Boxed warning, Warnings, Adverse reactions | 202446 ANDA202446 |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 58ff9a82-5de6-a1b0-e053-2991aa0a84ba | 2024-07-18 | Boxed warning, Warnings, Adverse reactions | 202446 ANDA202446 68071-4092 |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 5a5a4040-5395-54ac-e053-2991aa0aa4ab | 2024-07-18 | Boxed warning, Warnings, Adverse reactions | 202446 ANDA202446 68071-4104 |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | A-S Medication Solutions | 9440dd10-2f0d-42a7-a037-3ab8729708f6 | 2023-01-03 | Boxed warning, Warnings, Adverse reactions | 202446 ANDA202446 |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Proficient Rx LP | df5aee40-ffa9-4cf3-ab5f-30253f43092b | 2022-05-02 | Boxed warning, Warnings, Adverse reactions | 202446 ANDA202446 63187-637 |
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 |
|---|---|---|---|---|---|
| 61919-076 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 61919-076 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 61919-117 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 61919-117 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 61919-117 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 61919-117 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 61919-117 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 61919-117 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 61919-223 | Amitriptyline hcl | Amitriptyline hcl | Direct Rx | ANDA | Current |
| 61919-289 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Direct Rx | ANDA | Current |
| 61919-289 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | DIRECT RX | ANDA | Current |
| 61919-289 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Direct_Rx | ANDA | Current |
| 61919-289 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Direct_Rx | ANDA | Current |
| 61919-374 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Direct Rx | ANDA | Current |
| 61919-374 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 61919-374 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 63187-359 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 63187-359 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 63187-359 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 63187-359 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 63187-408 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 63187-408 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 63187-408 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 63187-408 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 63187-408 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 63187-637 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 63187-637 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 63187-637 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 63187-637 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 63629-8022 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 63629-8022 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 66267-018 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-018 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-019 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-019 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-020 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-020 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 67046-029 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-034 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-035 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Contract Pharmacy Services-PA | ANDA | Current |
| 67296-1816 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1816 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | RedPharm Drug, Inc. | ANDA | Current |
| 68071-1368 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1797 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3131 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-4092 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4092 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4104 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4104 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4104 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4108 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4108 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4108 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4408 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4408 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4408 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4662 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4720 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4720 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5220 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5220 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-6320 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Preferred Pharamaceuticals Inc. | ANDA | Current |
| 68788-6320 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Preferred Pharamaceuticals Inc. | ANDA | Current |
| 68788-6320 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Preferred Pharamaceuticals Inc. | ANDA | Current |
| 68788-6320 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Preferred Pharamaceuticals Inc. | ANDA | Current |
| 68788-6320 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Preferred Pharamaceuticals Inc. | ANDA | Current |
| 68788-6432 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6432 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6432 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6432 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6432 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6825 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6825 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6825 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6825 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6825 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6899 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6899 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6899 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6899 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ANDA | Current |