Application 216243
- Type
- ANDA
- Sponsor
- CENTAUR PHARMS PVT
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 |
|---|---|---|---|---|---|---|---|
| A216243-001 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2022-06-06 | ||
| A216243-002 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2022-06-06 | ||
| A216243-003 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2022-06-06 | ||
| A216243-004 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | 2022-06-06 | ||
| A216243-005 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2022-06-06 | ||
| A216243-006 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2022-06-06 |
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 | A216243-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2022-06-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A216243-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2022-06-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A216243-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2022-06-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A216243-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | 2022-06-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A216243-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2022-06-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A216243-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2022-06-06 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A216243-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2022-06-06 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A216243-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2022-06-06 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A216243-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2022-06-06 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A216243-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | 2022-06-06 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A216243-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2022-06-06 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A216243-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2022-06-06 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A216243-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2022-06-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A216243-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2022-06-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A216243-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2022-06-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A216243-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | 2022-06-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A216243-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2022-06-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A216243-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2022-06-06 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216243-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2022-06-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216243-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2022-06-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216243-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2022-06-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216243-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | 2022-06-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216243-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2022-06-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216243-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2022-06-06 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A216243-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2022-06-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216243-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2022-06-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216243-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2022-06-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216243-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2022-06-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216243-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2022-06-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216243-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2022-06-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216243-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2022-06-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216243-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2022-06-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216243-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2022-06-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216243-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2022-06-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216243-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2022-06-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216243-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2022-06-06 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216243-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2022-06-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216243-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2022-06-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216243-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2022-06-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216243-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2022-06-06 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216243-005 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216243-006 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A216243-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A216243-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A216243-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A216243-004 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A216243-005 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A216243-006 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216243-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216243-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216243-003 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216243-004 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216243-005 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216243-006 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216243-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216243-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216243-003 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216243-004 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216243-005 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216243-006 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216243-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216243-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216243-003 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216243-004 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216243-005 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216243-006 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A216243-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A216243-002 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A216243-003 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A216243-004 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A216243-005 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A216243-006 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A216243-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A216243-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A216243-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A216243-004 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A216243-005 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A216243-006 | AB | 1 | 5c6f7cd8ea54… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A216243-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A216243-002 | AB | 1 | 6a51e52b5d6a… |
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 | Centaur Pharmaceuticals Private Limited | 3d113e43-c694-427f-8b77-66be36a82374 | 2022-09-16 | Boxed warning, Warnings, Adverse reactions | 216243 ANDA216243 64330-632 64330-633 64330-630 64330-631 64330-634 64330-635 |
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 |
|---|---|---|---|---|---|
| 64330-630 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Centaur Pharmaceuticals Private Limited | ANDA | Current |
| 64330-631 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Centaur Pharmaceuticals Private Limited | ANDA | Current |
| 64330-632 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Centaur Pharmaceuticals Private Limited | ANDA | Current |
| 64330-633 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Centaur Pharmaceuticals Private Limited | ANDA | Current |
| 64330-634 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Centaur Pharmaceuticals Private Limited | ANDA | Current |
| 64330-635 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Centaur Pharmaceuticals Private Limited | ANDA | Current |