Application 040218
- Type
- ANDA
- Sponsor
- VINTAGE 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 |
|---|---|---|---|---|---|---|---|
| A040218-001 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1997-09-11 | ||
| A040218-002 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 1997-09-11 | ||
| A040218-003 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 1997-09-11 | ||
| A040218-004 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | 1997-09-11 | ||
| A040218-005 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 1997-09-11 | ||
| A040218-006 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | 1997-09-11 |
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 | A040218-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1997-09-11 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040218-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 1997-09-11 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040218-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 1997-09-11 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040218-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | 1997-09-11 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040218-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 1997-09-11 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040218-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | 1997-09-11 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040218-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1997-09-11 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040218-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 1997-09-11 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040218-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 1997-09-11 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040218-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | 1997-09-11 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040218-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 1997-09-11 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040218-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | 1997-09-11 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040218-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1997-09-11 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040218-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 1997-09-11 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040218-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 1997-09-11 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040218-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | 1997-09-11 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040218-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 1997-09-11 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040218-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | 1997-09-11 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040218-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1997-09-11 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040218-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 1997-09-11 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040218-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 1997-09-11 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040218-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | 1997-09-11 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040218-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 1997-09-11 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040218-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | 1997-09-11 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040218-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1997-09-11 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040218-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 1997-09-11 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040218-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 1997-09-11 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040218-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | 1997-09-11 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040218-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 1997-09-11 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040218-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | 1997-09-11 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040218-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1997-09-11 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040218-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 1997-09-11 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040218-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 1997-09-11 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040218-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | 1997-09-11 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040218-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 1997-09-11 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040218-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | 1997-09-11 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040218-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1997-09-11 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040218-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 1997-09-11 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040218-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 1997-09-11 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040218-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | 1997-09-11 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040218-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040218-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040218-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040218-004 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040218-005 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040218-006 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A040218-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A040218-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A040218-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A040218-004 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A040218-005 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A040218-006 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A040218-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A040218-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A040218-003 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A040218-004 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A040218-005 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A040218-006 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A040218-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A040218-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A040218-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A040218-004 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A040218-005 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A040218-006 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A040218-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A040218-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A040218-003 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A040218-004 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A040218-005 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A040218-006 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A040218-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A040218-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A040218-003 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A040218-004 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A040218-005 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A040218-006 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040218-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040218-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040218-003 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040218-004 | AB | 1 | 87673890dc5c… |
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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0463-6351 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | C.O. Truxton, Inc. | ANDA | Current |
| 0463-6352 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | C.O. Truxton, Inc. | ANDA | Current |
| 0463-6354 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | C.O. Truxton, Inc. | ANDA | Current |
| 0603-2212 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Par Pharmaceutical | ANDA | Current |
| 0603-2212 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Par Pharmaceutical | ANDA | Current |
| 0603-2212 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 0603-2213 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Par Pharmaceutical | ANDA | Current |
| 0603-2213 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Par Pharmaceutical | ANDA | Current |
| 0603-2213 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 0603-2214 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Par Pharmaceutical | ANDA | Current |
| 0603-2214 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Par Pharmaceutical | ANDA | Current |
| 0603-2214 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 0603-2215 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Par Pharmaceutical | ANDA | Current |
| 0603-2215 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Par Pharmaceutical | ANDA | Current |
| 0603-2215 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 0603-2216 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Par Pharmaceutical | ANDA | Current |
| 0603-2216 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Par Pharmaceutical | ANDA | Current |
| 0603-2216 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 0603-2217 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Par Pharmaceutical | ANDA | Current |
| 0603-2217 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Par Pharmaceutical | ANDA | Current |
| 0603-2217 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 33261-007 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-358 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-363 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-459 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-626 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-944 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 35356-712 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | ANDA | Current |
| 35356-759 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 43063-193 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-336 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 49999-228 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 50090-0030 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-0031 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-0264 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-0264 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-0264 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-0264 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-0333 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50436-3073 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Unit Dose Services | ANDA | Current |
| 55289-016 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-124 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-124 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-124 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-124 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-730 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55700-241 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-391 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 61919-011 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 61919-240 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 63187-155 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-155 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-156 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-156 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-229 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-229 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-260 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-260 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63629-1368 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1368 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2115 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2115 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2116 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2116 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2117 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2117 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2118 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2118 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2119 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2119 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2120 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2120 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2121 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2121 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2122 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2122 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2123 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2123 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-6630 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8987 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Bryant Ranch Prepack | ANDA | Current |