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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A040218-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1997-09-11 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A040218-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 1997-09-11 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A040218-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 1997-09-11 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A040218-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | 1997-09-11 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A040218-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 1997-09-11 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A040218-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | 1997-09-11 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040218-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1997-09-11 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040218-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 1997-09-11 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040218-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 1997-09-11 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040218-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | 1997-09-11 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040218-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 1997-09-11 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040218-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | 1997-09-11 | caaa826d4ba7… | ||
| 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… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | A-S Medication Solutions | 00d11130-c9ae-4258-9746-9763bc5deb84 | 2023-12-22 | Boxed warning, Warnings, Adverse reactions | Amitriptyline Hydrochloride AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | A-S Medication Solutions | 5e8c8c5f-4964-4642-ad4b-69a75b2c8a02 | 2023-12-18 | Boxed warning, Warnings, Adverse reactions | Amitriptyline Hydrochloride AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | A-S Medication Solutions | d22879c5-925a-42e0-9d48-55a422192983 | 2023-12-18 | Boxed warning, Warnings, Adverse reactions | Amitriptyline Hydrochloride AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Proficient Rx LP | 6dc9d113-1156-43ec-a7eb-253c2ff6bcfa | 2023-12-01 | Boxed warning, Warnings, Adverse reactions | Amitriptyline Hydrochloride AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 25832051-837b-4682-8548-5ab9a1b7cdac | 2023-11-14 | Boxed warning, Warnings, Adverse reactions | Amitriptyline Hydrochloride AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 4e0f3b15-3621-48a1-9f2b-b0a373920360 | 2023-09-15 | Boxed warning, Warnings, Adverse reactions | Amitriptyline Hydrochloride AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Proficient Rx LP | e42225f5-44bd-451e-98a1-aa3877457733 | 2023-08-04 | Boxed warning, Warnings, Adverse reactions | Amitriptyline Hydrochloride AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | A-S Medication Solutions | 1a622039-0a79-407c-8f15-2ea0c5844136 | 2023-04-07 | Boxed warning, Warnings, Adverse reactions | Amitriptyline Hydrochloride AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 8746c047-51b9-4040-aeec-cd1f5b6eb3d4 | 2023-03-20 | Boxed warning, Warnings, Adverse reactions | Amitriptyline Hydrochloride AMITRIPTYLINE HYDROCHLORIDE |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | A-S Medication Solutions | 9440dd10-2f0d-42a7-a037-3ab8729708f6 | 2023-01-03 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Centaur Pharmaceuticals Private Limited | 3d113e43-c694-427f-8b77-66be36a82374 | 2022-09-16 | Boxed warning, Warnings, Adverse reactions | Amitriptyline Hydrochloride AMITRIPTYLINE HYDROCHLORIDE |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Proficient Rx LP | df5aee40-ffa9-4cf3-ab5f-30253f43092b | 2022-05-02 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE |
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 |
|---|---|---|---|---|---|
| 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 |