Application 208127
- Type
- ANDA
- Sponsor
- CROSSMEDIKA SA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRIMIPRAMINE MALEATE | TRIMIPRAMINE MALEATE | CAPSULE;ORAL | EQ 25MG BASE | No | No |
| 002 | TRIMIPRAMINE MALEATE | TRIMIPRAMINE MALEATE | CAPSULE;ORAL | EQ 50MG BASE | No | Yes |
| 003 | TRIMIPRAMINE MALEATE | TRIMIPRAMINE MALEATE | CAPSULE;ORAL | EQ 100MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A208127-001 | TRIMIPRAMINE MALEATE | TRIMIPRAMINE MALEATE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2016-04-15 | |
| A208127-002 | TRIMIPRAMINE MALEATE | TRIMIPRAMINE MALEATE | EQ 50MG BASE | CAPSULE / ORAL | AB | RS | 2016-04-15 |
| A208127-003 | TRIMIPRAMINE MALEATE | TRIMIPRAMINE MALEATE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2016-04-15 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A208127-001 | AB |
| A208127-002 | AB |
| A208127-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2023-01-26 05:58 UTC | 2023-01 | A208127-001 | TRIMIPRAMINE MALEATE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2016-04-15 | 3bdfa0b2c4d7… | |
| 2023-01-26 05:58 UTC | 2023-01 | A208127-002 | TRIMIPRAMINE MALEATE | EQ 50MG BASE | CAPSULE / ORAL | AB | RS | 2016-04-15 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A208127-003 | TRIMIPRAMINE MALEATE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2016-04-15 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A208127-001 | TRIMIPRAMINE MALEATE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2016-04-15 | 3a93d1ddd44b… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A208127-002 | TRIMIPRAMINE MALEATE | EQ 50MG BASE | CAPSULE / ORAL | AB | RS | 2016-04-15 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A208127-003 | TRIMIPRAMINE MALEATE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2016-04-15 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A208127-001 | TRIMIPRAMINE MALEATE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2016-04-15 | f41ea6bd6efb… | |
| 2022-10-28 04:53 UTC | 2022-10 | A208127-002 | TRIMIPRAMINE MALEATE | EQ 50MG BASE | CAPSULE / ORAL | AB | RS | 2016-04-15 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A208127-003 | TRIMIPRAMINE MALEATE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2016-04-15 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A208127-001 | TRIMIPRAMINE MALEATE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2016-04-15 | e64feba35796… | |
| 2022-09-29 23:25 UTC | 2022-09 | A208127-002 | TRIMIPRAMINE MALEATE | EQ 50MG BASE | CAPSULE / ORAL | AB | RS | 2016-04-15 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A208127-003 | TRIMIPRAMINE MALEATE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2016-04-15 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A208127-001 | TRIMIPRAMINE MALEATE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2016-04-15 | cb3db0bc1861… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A208127-002 | TRIMIPRAMINE MALEATE | EQ 50MG BASE | CAPSULE / ORAL | AB | RS | 2016-04-15 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A208127-003 | TRIMIPRAMINE MALEATE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2016-04-15 | cb3db0bc1861… | |
| 2026-08-01 22:54:32 | 2026-06 | A208127-001 | TRIMIPRAMINE MALEATE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2016-04-15 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A208127-002 | TRIMIPRAMINE MALEATE | EQ 50MG BASE | CAPSULE / ORAL | AB | RS | 2016-04-15 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A208127-003 | TRIMIPRAMINE MALEATE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2016-04-15 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2023-01-26 05:58 UTC | 2023-01 | A208127-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A208127-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A208127-003 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A208127-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A208127-002 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A208127-003 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A208127-001 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A208127-002 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A208127-003 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A208127-001 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A208127-002 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A208127-003 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A208127-001 | AB | 1 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A208127-002 | AB | 1 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A208127-003 | AB | 1 | cb3db0bc1861… |
| 2026-08-01 22:54:32 | 2026-06 | A208127-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A208127-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A208127-003 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Trimipramine | TRIMIPRAMINE | Breckenridge Pharmaceutical, Inc. | 4f31df66-7dc2-1f04-e054-00144ff88e88 | 2026-03-17 | Boxed warning, Warnings, Adverse reactions | 208127 ANDA208127 51991-945 51991-946 51991-944 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 51991-944 | Trimipramine Maleate | Trimipramine Maleate | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-944 | Trimipramine Maleate | Trimipramine Maleate | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-944 | Trimipramine Maleate | Trimipramine Maleate | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-944 | Trimipramine Maleate | Trimipramine Maleate | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-944 | Trimipramine Maleate | Trimipramine Maleate | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-944 | Trimipramine Maleate | Trimipramine Maleate | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-944 | Trimipramine Maleate | Trimipramine Maleate | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-945 | Trimipramine Maleate | Trimipramine Maleate | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-945 | Trimipramine Maleate | Trimipramine Maleate | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-945 | Trimipramine Maleate | Trimipramine Maleate | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-945 | Trimipramine Maleate | Trimipramine Maleate | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-945 | Trimipramine Maleate | Trimipramine Maleate | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-945 | Trimipramine Maleate | Trimipramine Maleate | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-945 | Trimipramine Maleate | Trimipramine Maleate | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-946 | Trimipramine Maleate | Trimipramine Maleate | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-946 | Trimipramine Maleate | Trimipramine Maleate | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-946 | Trimipramine Maleate | Trimipramine Maleate | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-946 | Trimipramine Maleate | Trimipramine Maleate | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-946 | Trimipramine Maleate | Trimipramine Maleate | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-946 | Trimipramine Maleate | Trimipramine Maleate | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-946 | Trimipramine Maleate | Trimipramine Maleate | Breckenridge Pharmaceutical, Inc. | ANDA | Current |