Application 205153
- Type
- ANDA
- Sponsor
- ANI PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 002 | DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | TABLET;ORAL | 25MG | No | No |
| 003 | DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | TABLET;ORAL | 50MG | No | No |
| 004 | DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | TABLET;ORAL | 75MG | No | No |
| 005 | DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No |
| 006 | DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | TABLET;ORAL | 150MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A205153-001 | DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2016-10-28 | ||
| A205153-002 | DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2016-10-28 | ||
| A205153-003 | DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2016-10-28 | ||
| A205153-004 | DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 75MG | TABLET / ORAL | 2016-10-28 | ||
| A205153-005 | DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2016-10-28 | ||
| A205153-006 | DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2016-10-28 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205153-005 | DESIPRAMINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2016-10-28 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205153-006 | DESIPRAMINE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2016-10-28 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205153-001 | DESIPRAMINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2016-10-28 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205153-002 | DESIPRAMINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2016-10-28 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205153-003 | DESIPRAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2016-10-28 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205153-004 | DESIPRAMINE HYDROCHLORIDE | 75MG | TABLET / ORAL | 2016-10-28 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205153-005 | DESIPRAMINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2016-10-28 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205153-006 | DESIPRAMINE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2016-10-28 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205153-001 | DESIPRAMINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2016-10-28 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205153-002 | DESIPRAMINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2016-10-28 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205153-003 | DESIPRAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2016-10-28 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205153-004 | DESIPRAMINE HYDROCHLORIDE | 75MG | TABLET / ORAL | 2016-10-28 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205153-005 | DESIPRAMINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2016-10-28 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205153-006 | DESIPRAMINE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2016-10-28 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205153-001 | DESIPRAMINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2016-10-28 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205153-002 | DESIPRAMINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2016-10-28 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205153-003 | DESIPRAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2016-10-28 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205153-004 | DESIPRAMINE HYDROCHLORIDE | 75MG | TABLET / ORAL | 2016-10-28 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205153-005 | DESIPRAMINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2016-10-28 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205153-006 | DESIPRAMINE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2016-10-28 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205153-001 | DESIPRAMINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2016-10-28 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205153-002 | DESIPRAMINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2016-10-28 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205153-003 | DESIPRAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2016-10-28 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205153-004 | DESIPRAMINE HYDROCHLORIDE | 75MG | TABLET / ORAL | 2016-10-28 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205153-005 | DESIPRAMINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2016-10-28 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205153-006 | DESIPRAMINE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2016-10-28 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205153-001 | DESIPRAMINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2016-10-28 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205153-002 | DESIPRAMINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2016-10-28 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205153-003 | DESIPRAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2016-10-28 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205153-004 | DESIPRAMINE HYDROCHLORIDE | 75MG | TABLET / ORAL | 2016-10-28 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205153-005 | DESIPRAMINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2016-10-28 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205153-006 | DESIPRAMINE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2016-10-28 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A205153-001 | DESIPRAMINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2016-10-28 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A205153-002 | DESIPRAMINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2016-10-28 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A205153-003 | DESIPRAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2016-10-28 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A205153-004 | DESIPRAMINE HYDROCHLORIDE | 75MG | TABLET / ORAL | 2016-10-28 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A205153-005 | DESIPRAMINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2016-10-28 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A205153-006 | DESIPRAMINE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2016-10-28 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205153-001 | DESIPRAMINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2016-10-28 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205153-002 | DESIPRAMINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2016-10-28 | 79d66fd596c7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A205153-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A205153-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A205153-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A205153-004 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A205153-005 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A205153-006 | AB | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A205153-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A205153-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A205153-003 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A205153-004 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A205153-005 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A205153-006 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A205153-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A205153-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A205153-003 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A205153-004 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A205153-005 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A205153-006 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A205153-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A205153-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A205153-003 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A205153-004 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A205153-005 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A205153-006 | AB | 1 | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | REMEDYREPACK INC. | dc1601be-e16a-411f-b9b8-01c51abb2441 | 2026-04-28 | Boxed warning, Warnings, Adverse reactions | DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE |
| Desipramine Hydrochloride | DESIPRAMINE HYDROCHLORIDE | Chartwell RX, LLC | 6ab5e113-82ef-493d-a4e3-a2756608fa60 | 2025-12-09 | Boxed warning, Warnings, Adverse reactions | Desipramine Hydrochloride DESIPRAMINE HYDROCHLORIDE |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ee14dd2c-c54b-4cd1-a3a0-f7ad5a5a0ed0 | 2025-08-26 | Boxed warning, Warnings, Adverse reactions | DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | Ingenus Pharmaceuticals, LLC | 7280f157-3fff-41c5-b3f4-510b8bacdaba | 2025-07-30 | Boxed warning, Warnings, Adverse reactions | DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | Alembic Pharmaceuticals Inc. | cad14805-64d8-4257-b5f1-d56e0063f0e2 | 2025-07-09 | Boxed warning, Warnings, Adverse reactions | DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE |
| Norpramin | DESIPRAMINE HYDROCHLORIDE | Validus Pharmaceuticals LLC | 70b562ea-9f21-4e4a-b3ed-0590b2892f6a | 2025-07-03 | Boxed warning, Warnings, Adverse reactions | DESIPRAMINE HYDROCHLORIDE |
| Desipramine Hydrochloride | DESIPRAMINE HYDROCHLORIDE | Actavis Pharma, Inc. | ba02a95d-d82e-4a13-90b4-a219abc0249a | 2025-07-01 | Boxed warning, Warnings, Adverse reactions | Desipramine Hydrochloride DESIPRAMINE HYDROCHLORIDE |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | Alembic Pharmaceuticals Limited | 8b6d2289-aac9-4007-a73d-c168fd2e1d9e | 2023-01-27 | Boxed warning, Warnings, Adverse reactions | DESIPRAMINE HYDROCHLORIDE DESIPRAMINE 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 |
|---|---|---|---|---|---|
| 62559-710 | Desipramine Hydrochloride | Desipramine Hydrochloride | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-710 | Desipramine Hydrochloride | Desipramine Hydrochloride | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-710 | Desipramine Hydrochloride | Desipramine Hydrochloride | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-711 | Desipramine Hydrochloride | Desipramine Hydrochloride | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-711 | Desipramine Hydrochloride | Desipramine Hydrochloride | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-711 | Desipramine Hydrochloride | Desipramine Hydrochloride | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-712 | Desipramine Hydrochloride | Desipramine Hydrochloride | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-712 | Desipramine Hydrochloride | Desipramine Hydrochloride | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-712 | Desipramine Hydrochloride | Desipramine Hydrochloride | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-713 | Desipramine Hydrochloride | Desipramine Hydrochloride | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-713 | Desipramine Hydrochloride | Desipramine Hydrochloride | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-713 | Desipramine Hydrochloride | Desipramine Hydrochloride | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-714 | Desipramine Hydrochloride | Desipramine Hydrochloride | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-714 | Desipramine Hydrochloride | Desipramine Hydrochloride | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-714 | Desipramine Hydrochloride | Desipramine Hydrochloride | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-715 | Desipramine Hydrochloride | Desipramine Hydrochloride | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-715 | Desipramine Hydrochloride | Desipramine Hydrochloride | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-715 | Desipramine Hydrochloride | Desipramine Hydrochloride | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 64720-415 | Desipramine Hydrochloride | Desipramine Hydrochloride | CorePharma, LLC | ANDA | Current |
| 64720-416 | Desipramine Hydrochloride | desipramine hydrochloride | CorePharma, LLC | ANDA | Current |
| 64720-417 | Desipramine Hydrochloride | Desipramine Hydrochloride | CorePharma, LLC | ANDA | Current |
| 64720-420 | Desipramine Hydrochloride | Desipramine Hydrochloride | CorePharma, LLC | ANDA | Current |
| 68788-7552 | Desipramine Hydrochloride | Desipramine Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7552 | Desipramine Hydrochloride | Desipramine Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |