Application 083639
- Type
- ANDA
- Sponsor
- ROCHE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ENDEP | AMITRIPTYLINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 002 | ENDEP | AMITRIPTYLINE HYDROCHLORIDE | TABLET;ORAL | 25MG | No | No |
| 003 | ENDEP | AMITRIPTYLINE HYDROCHLORIDE | TABLET;ORAL | 50MG | No | No |
| 004 | ENDEP | AMITRIPTYLINE HYDROCHLORIDE | TABLET;ORAL | 75MG | No | No |
| 005 | ENDEP | AMITRIPTYLINE HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A083639-001 | ENDEP | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | Approved before 1982 | ||
| A083639-002 | ENDEP | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | Approved before 1982 | ||
| A083639-003 | ENDEP | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | Approved before 1982 | ||
| A083639-004 | ENDEP | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | Approved before 1982 | ||
| A083639-005 | ENDEP | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | Approved before 1982 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A083639-001 | ENDEP | 10MG | TABLET / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A083639-002 | ENDEP | 25MG | TABLET / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A083639-003 | ENDEP | 50MG | TABLET / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A083639-004 | ENDEP | 75MG | TABLET / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A083639-005 | ENDEP | 100MG | TABLET / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A083639-001 | ENDEP | 10MG | TABLET / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A083639-002 | ENDEP | 25MG | TABLET / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A083639-003 | ENDEP | 50MG | TABLET / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A083639-004 | ENDEP | 75MG | TABLET / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A083639-005 | ENDEP | 100MG | TABLET / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A083639-001 | ENDEP | 10MG | TABLET / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A083639-002 | ENDEP | 25MG | TABLET / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A083639-003 | ENDEP | 50MG | TABLET / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A083639-004 | ENDEP | 75MG | TABLET / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A083639-005 | ENDEP | 100MG | TABLET / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A083639-001 | ENDEP | 10MG | TABLET / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A083639-002 | ENDEP | 25MG | TABLET / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A083639-003 | ENDEP | 50MG | TABLET / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A083639-004 | ENDEP | 75MG | TABLET / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A083639-005 | ENDEP | 100MG | TABLET / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A083639-001 | ENDEP | 10MG | TABLET / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A083639-002 | ENDEP | 25MG | TABLET / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A083639-003 | ENDEP | 50MG | TABLET / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A083639-004 | ENDEP | 75MG | TABLET / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A083639-005 | ENDEP | 100MG | TABLET / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A083639-001 | ENDEP | 10MG | TABLET / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A083639-002 | ENDEP | 25MG | TABLET / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A083639-003 | ENDEP | 50MG | TABLET / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A083639-004 | ENDEP | 75MG | TABLET / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A083639-005 | ENDEP | 100MG | TABLET / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A083639-001 | ENDEP | 10MG | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A083639-002 | ENDEP | 25MG | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A083639-003 | ENDEP | 50MG | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A083639-004 | ENDEP | 75MG | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A083639-005 | ENDEP | 100MG | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A083639-001 | ENDEP | 10MG | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A083639-002 | ENDEP | 25MG | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A083639-003 | ENDEP | 50MG | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A083639-004 | ENDEP | 75MG | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A083639-005 | ENDEP | 100MG | TABLET / ORAL | Approved before 1982 | 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 | REMEDYREPACK INC. | abf6a3f5-0df9-4b23-995d-63b973ef80c1 | 2026-08-14 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | REMEDYREPACK INC. | c66e9088-4f34-4b97-971e-5272b45cfc97 | 2026-08-14 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Northwind Health Company, LLC | 471b99ac-395c-3137-e063-6394a90af18d | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 35aa7ab3-321a-97f7-e063-6294a90a91e2 | 2026-06-30 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Bryant Ranch Prepack | 16364b31-4b8b-481a-a553-e8974c0e557c | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | e3dd745a-57f5-4925-e053-2995a90a43c0 | 2026-06-16 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | REMEDYREPACK INC. | 5dc3c2d7-60a2-4754-be33-1f9401c925a4 | 2026-06-12 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | REMEDYREPACK INC. | 9ced0126-d597-48fb-96d3-577333760048 | 2026-06-11 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 1b2d2bb8-78c8-7e8e-e063-6294a90a2576 | 2026-06-04 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | REMEDYREPACK INC. | ce87013b-bf4a-47d1-9808-7cb8290feb23 | 2026-05-01 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Coupler LLC | 5070fa18-ecc9-de14-e063-6394a90a372e | 2026-04-27 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Coupler LLC | 50375dab-97fe-8c84-e063-6394a90a60b2 | 2026-04-24 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Coupler LLC | 500f239c-0460-a22b-e063-6294a90a1ba6 | 2026-04-22 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Bryant Ranch Prepack | 9f9d6495-47ff-4dcf-9643-ebd5cd7499cb | 2026-04-10 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Lifestar Pharma LLC | 67e31675-1da2-4acf-84ac-77522b02f0b9 | 2026-04-08 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Aurobindo Pharma Limited | 8085a37f-3c76-4f74-aab3-9a929a7eb1c2 | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | A-S Medication Solutions | 53f4f83c-4bfd-43d6-9bb8-82c21ed2864f | 2026-03-23 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | A-S Medication Solutions | 9d00b912-69be-4d9a-8c81-42cfc9bf6e09 | 2026-03-18 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 451b8742-8b3c-4335-9075-c1d8313cd3d0 | 2026-02-26 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 6f0c2fd1-0e0d-4f5f-80c4-266fcee09fa8 | 2026-02-23 | Boxed warning, Warnings, Adverse reactions | AMITRIPTYLINE HYDROCHLORIDE |