Application 019880
- Type
- NDA
- Sponsor
- CORDEN PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PARAPLATIN | CARBOPLATIN | INJECTABLE;INJECTION | 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | PARAPLATIN | CARBOPLATIN | INJECTABLE;INJECTION | 150MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | PARAPLATIN | CARBOPLATIN | INJECTABLE;INJECTION | 450MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019880-001 | PARAPLATIN | CARBOPLATIN | 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | |
| N019880-002 | PARAPLATIN | CARBOPLATIN | 150MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | |
| N019880-003 | PARAPLATIN | CARBOPLATIN | 450MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 |
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| 2026-07 | N019880-001 | PARAPLATIN | 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019880-002 | PARAPLATIN | 150MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019880-003 | PARAPLATIN | 450MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019880-001 | PARAPLATIN | 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019880-002 | PARAPLATIN | 150MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019880-003 | PARAPLATIN | 450MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019880-001 | PARAPLATIN | 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019880-002 | PARAPLATIN | 150MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019880-003 | PARAPLATIN | 450MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019880-001 | PARAPLATIN | 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019880-002 | PARAPLATIN | 150MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019880-003 | PARAPLATIN | 450MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019880-001 | PARAPLATIN | 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019880-002 | PARAPLATIN | 150MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019880-003 | PARAPLATIN | 450MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019880-001 | PARAPLATIN | 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019880-002 | PARAPLATIN | 150MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019880-003 | PARAPLATIN | 450MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019880-001 | PARAPLATIN | 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019880-002 | PARAPLATIN | 150MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019880-003 | PARAPLATIN | 450MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019880-001 | PARAPLATIN | 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019880-002 | PARAPLATIN | 150MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019880-003 | PARAPLATIN | 450MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019880-001 | PARAPLATIN | 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019880-002 | PARAPLATIN | 150MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019880-003 | PARAPLATIN | 450MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019880-001 | PARAPLATIN | 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019880-002 | PARAPLATIN | 150MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019880-003 | PARAPLATIN | 450MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019880-001 | PARAPLATIN | 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019880-002 | PARAPLATIN | 150MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019880-003 | PARAPLATIN | 450MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019880-001 | PARAPLATIN | 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019880-002 | PARAPLATIN | 150MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019880-003 | PARAPLATIN | 450MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019880-001 | PARAPLATIN | 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019880-002 | PARAPLATIN | 150MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019880-003 | PARAPLATIN | 450MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019880-001 | PARAPLATIN | 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-03-03 | 1e350fbaab3a… |
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 |
|---|---|---|---|---|---|---|
| CARBOPLATIN | CARBOPLATIN | Natco Pharma USA LLC | 4c89cedc-e48b-445c-ad05-54dbe60e4fb0 | 2026-07-21 | Boxed warning, Warnings, Adverse reactions | CARBOPLATIN |
| CARBOPLATIN | CARBOPLATIN | BPI Labs LLC | 5484d2f0-0cc2-4bba-8f26-c7f6539a9606 | 2025-12-26 | Boxed warning, Warnings, Adverse reactions | CARBOPLATIN |
| KYXATA | CARBOPLATIN | Avyxa Pharma, LLC | f91c48da-68d1-4aa7-89b8-d84a3e8b629b | 2025-09-02 | Boxed warning, Warnings, Adverse reactions | CARBOPLATIN |
| Carboplatin | CARBOPLATIN | Accord Healthcare, Inc. | 48aa7ef3-9f44-2a08-e054-00144ff88e88 | 2025-05-23 | Boxed warning, Warnings, Adverse reactions | CARBOPLATIN |
| CARBOPLATIN | CARBOPLATIN | Eugia US LLC | 5abfcb87-bb02-4384-9c9d-7d0e3e809311 | 2025-01-30 | Boxed warning, Warnings, Adverse reactions | CARBOPLATIN |
| CARBOPLATIN | CARBOPLATIN | Eugia US LLC | f5fe9a20-47a5-45b9-ab06-c6158d9b6aca | 2025-01-10 | Boxed warning, Warnings, Adverse reactions | CARBOPLATIN |
| CARBOPLATIN | CARBOPLATIN | Teyro Labs Private Limited | f64a0cbe-7fe3-407e-8933-21c30e1a1ebc | 2025-01-08 | Boxed warning, Warnings, Adverse reactions | CARBOPLATIN |
| Carboplatin | CARBOPLATIN | Hospira, Inc. | 47677091-fd20-49af-933c-c9dd2be21de9 | 2024-08-21 | Boxed warning, Warnings, Adverse reactions | CARBOPLATIN |
| Carboplatin | CARBOPLATIN | Hospira, Inc. | c3ae9880-44bb-4f4e-93d8-8a5e21708a30 | 2024-06-20 | Boxed warning, Warnings, Adverse reactions | CARBOPLATIN |
| CARBOPLATIN | CARBOPLATIN | Apotex Corp. | 1c275825-0275-4c73-b650-e4c1519f13b8 | 2024-01-07 | Boxed warning, Warnings, Adverse reactions | CARBOPLATIN |
| CARBOPLATIN | CARBOPLATIN | Gland Pharma Limited | 9eb057eb-29ce-40d2-9ac8-ed107f25f5ab | 2023-11-09 | Boxed warning, Warnings, Adverse reactions | CARBOPLATIN |
| Carboplatin | CARBOPLATIN | Teva Parenteral Medicines, Inc. | e176b6ef-2ff6-498b-a9d8-7a634d147f37 | 2022-08-30 | Boxed warning, Warnings, Adverse reactions | CARBOPLATIN |
| Carboplatin | CARBOPLATIN | Fresenius Kabi USA, LLC | b4fa7aac-c9d2-4af4-a281-3e6cfc502ff6 | 2021-07-07 | Boxed warning, Warnings, Adverse reactions | CARBOPLATIN |
| CARBOplatin | CARBOPLATIN | Teva Parenteral Medicines, Inc. | f330f5a2-2cad-402f-bcbb-26245a753276 | 2016-01-31 | Boxed warning, Warnings, Adverse reactions | CARBOPLATIN |