Application 077679
- Type
- ANDA
- Sponsor
- PHARMACHEMIE BV
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CARBOPLATIN | CARBOPLATIN | INJECTABLE;INTRAVENOUS | 50MG/5ML (10MG/ML) | No | No |
| 002 | CARBOPLATIN | CARBOPLATIN | INJECTABLE;INTRAVENOUS | 150MG/15ML (10MG/ML) | No | No |
| 003 | CARBOPLATIN | CARBOPLATIN | INJECTABLE;INTRAVENOUS | 450MG/45ML (10MG/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077679-001 | CARBOPLATIN | CARBOPLATIN | 50MG/5ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | ||
| A077679-002 | CARBOPLATIN | CARBOPLATIN | 150MG/15ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | ||
| A077679-003 | CARBOPLATIN | CARBOPLATIN | 450MG/45ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2020-11-12 02:37 UTC | 2020-11 | A077679-003 | CARBOPLATIN | 450MG/45ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A077679-001 | CARBOPLATIN | 50MG/5ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A077679-002 | CARBOPLATIN | 150MG/15ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A077679-003 | CARBOPLATIN | 450MG/45ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A077679-001 | CARBOPLATIN | 50MG/5ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A077679-002 | CARBOPLATIN | 150MG/15ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A077679-003 | CARBOPLATIN | 450MG/45ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A077679-001 | CARBOPLATIN | 50MG/5ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A077679-002 | CARBOPLATIN | 150MG/15ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A077679-003 | CARBOPLATIN | 450MG/45ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077679-001 | CARBOPLATIN | 50MG/5ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077679-002 | CARBOPLATIN | 150MG/15ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077679-003 | CARBOPLATIN | 450MG/45ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A077679-001 | CARBOPLATIN | 50MG/5ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A077679-002 | CARBOPLATIN | 150MG/15ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A077679-003 | CARBOPLATIN | 450MG/45ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A077679-001 | CARBOPLATIN | 50MG/5ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A077679-002 | CARBOPLATIN | 150MG/15ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A077679-003 | CARBOPLATIN | 450MG/45ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077679-001 | CARBOPLATIN | 50MG/5ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077679-002 | CARBOPLATIN | 150MG/15ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077679-003 | CARBOPLATIN | 450MG/45ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077679-001 | CARBOPLATIN | 50MG/5ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077679-002 | CARBOPLATIN | 150MG/15ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077679-003 | CARBOPLATIN | 450MG/45ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077679-001 | CARBOPLATIN | 50MG/5ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077679-002 | CARBOPLATIN | 150MG/15ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077679-003 | CARBOPLATIN | 450MG/45ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077679-001 | CARBOPLATIN | 50MG/5ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077679-002 | CARBOPLATIN | 150MG/15ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077679-003 | CARBOPLATIN | 450MG/45ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A077679-001 | CARBOPLATIN | 50MG/5ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A077679-002 | CARBOPLATIN | 150MG/15ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A077679-003 | CARBOPLATIN | 450MG/45ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A077679-001 | CARBOPLATIN | 50MG/5ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A077679-002 | CARBOPLATIN | 150MG/15ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A077679-003 | CARBOPLATIN | 450MG/45ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077679-001 | CARBOPLATIN | 50MG/5ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077679-002 | CARBOPLATIN | 150MG/15ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077679-003 | CARBOPLATIN | 450MG/45ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2009-02-25 | 3a93d1ddd44b… |
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 | CARBOPLATIN | BPI Labs LLC | 5484d2f0-0cc2-4bba-8f26-c7f6539a9606 | 2025-12-26 | Boxed warning, Warnings, Adverse reactions | CARBOPLATIN 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 | CARBOPLATIN | Eugia US LLC | 5abfcb87-bb02-4384-9c9d-7d0e3e809311 | 2025-01-30 | Boxed warning, Warnings, Adverse reactions | CARBOPLATIN CARBOPLATIN |
| CARBOPLATIN | CARBOPLATIN | Eugia US LLC | f5fe9a20-47a5-45b9-ab06-c6158d9b6aca | 2025-01-10 | Boxed warning, Warnings, Adverse reactions | CARBOPLATIN CARBOPLATIN |
| CARBOPLATIN | CARBOPLATIN | Teyro Labs Private Limited | f64a0cbe-7fe3-407e-8933-21c30e1a1ebc | 2025-01-08 | Boxed warning, Warnings, Adverse reactions | CARBOPLATIN CARBOPLATIN |
| Carboplatin | CARBOPLATIN | Hospira, Inc. | 47677091-fd20-49af-933c-c9dd2be21de9 | 2024-08-21 | Boxed warning, Warnings, Adverse reactions | Carboplatin CARBOPLATIN |
| Carboplatin | CARBOPLATIN | Hospira, Inc. | c3ae9880-44bb-4f4e-93d8-8a5e21708a30 | 2024-06-20 | Boxed warning, Warnings, Adverse reactions | Carboplatin CARBOPLATIN |
| CARBOPLATIN | CARBOPLATIN | Apotex Corp. | 1c275825-0275-4c73-b650-e4c1519f13b8 | 2024-01-07 | Boxed warning, Warnings, Adverse reactions | CARBOPLATIN CARBOPLATIN |
| CARBOPLATIN | CARBOPLATIN | Gland Pharma Limited | 9eb057eb-29ce-40d2-9ac8-ed107f25f5ab | 2023-11-09 | Boxed warning, Warnings, Adverse reactions | CARBOPLATIN CARBOPLATIN |
| Carboplatin | CARBOPLATIN | Teva Parenteral Medicines, Inc. | e176b6ef-2ff6-498b-a9d8-7a634d147f37 | 2022-08-30 | Boxed warning, Warnings, Adverse reactions | Carboplatin CARBOPLATIN |
| Carboplatin | CARBOPLATIN | Fresenius Kabi USA, LLC | b4fa7aac-c9d2-4af4-a281-3e6cfc502ff6 | 2021-07-07 | Boxed warning, Warnings, Adverse reactions | Carboplatin CARBOPLATIN |
| CARBOplatin | CARBOPLATIN | Teva Parenteral Medicines, Inc. | f330f5a2-2cad-402f-bcbb-26245a753276 | 2016-01-31 | Boxed warning, Warnings, Adverse reactions | CARBOplatin CARBOPLATIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.